Saws Suppliers
Limit companies to: Worldwide USA
Nadir & Co. | Address: Nadir & Co, Ugoki Road, Opp Small, Industrial Estate, Sialkot, Punjab 51340, Pakistan
www.nadirco.com | Send Inquiry | Phone: +92-(52)-3556741
FDA Registration: 3005897698 Quality: ISO 9001 : 2003 and ISO 13485 : 2003,CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), Bone Clamp (FDA Code: HXD), Disposable Surgical Instrument Kit (FDA Code: KDD), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Nadir & Co. manufactures surgical and diagnostic instruments. Our products line comprises of surgical instruments, dental instruments, orthodontic instruments, laboratory instruments and impression tr more...
www.nadirco.com | Send Inquiry | Phone: +92-(52)-3556741
FDA Registration: 3005897698 Quality: ISO 9001 : 2003 and ISO 13485 : 2003,CE Certified
Products: Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), Bone Clamp (FDA Code: HXD), Disposable Surgical Instrument Kit (FDA Code: KDD), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Nadir & Co. manufactures surgical and diagnostic instruments. Our products line comprises of surgical instruments, dental instruments, orthodontic instruments, laboratory instruments and impression tr more...
Adam Aids Corporation | Address: 14-A Small Industrial Estate, Sialkot, Punjab 51310, Pakistan
www.adamsaid.com | Send Inquiry | Phone: +92-(52)-3563425/26
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Adam Aids Corporation is engaged in the manufacture of surgical instruments, dental instruments, and veterinary products. Our surgical instruments include instruments for diagnostics, bone surgery, ne more...
www.adamsaid.com | Send Inquiry | Phone: +92-(52)-3563425/26
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), ENT Syringe (FDA Code: KCP), ENT Irrigation Syringe (FDA Code: KCP), Calipers (FDA Code: KTZ), Curettes (FDA Code: HTF), ...
Adam Aids Corporation is engaged in the manufacture of surgical instruments, dental instruments, and veterinary products. Our surgical instruments include instruments for diagnostics, bone surgery, ne more...
Lebord (Surgicals) | Address: Shahab Pura Road, Jamia Mosque Street#7, Sialkot, Punjab 51310, Pakistan
www.lebord.com | Send Inquiry | Phone: +92-(52)-3553747
Products: Bone Drills, Bone Chisels, Amputation Saws, Bone Holding Clamps, Bone Files, Bone currettes, ...
Lebord (Surgicals) is a manufacturer and exporters of medical & surgical instruments, surgical scissors, surgical forceps & beauty care instruments. We are an ISO certified company. Our products inclu more...
www.lebord.com | Send Inquiry | Phone: +92-(52)-3553747
Products: Bone Drills, Bone Chisels, Amputation Saws, Bone Holding Clamps, Bone Files, Bone currettes, ...
Lebord (Surgicals) is a manufacturer and exporters of medical & surgical instruments, surgical scissors, surgical forceps & beauty care instruments. We are an ISO certified company. Our products inclu more...
T.A. Walthem & Company | Address: P.B # 1767, Wazirabad road, Sialkot, Punjab PB 51310, Pakistan
www.tawalthem.com | Send Inquiry | Phone: +92-(52)-3255829
FDA Registration: 3003407244 Employee Count: ~1970 Quality: ISO 9002, ISO 13488, CE Mark Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
T.A. Walthem & Company is a manufacturer and exporter of medical & surgical instruments. Our product line includes eye needle holders, lid retractors, iris forceps, Graefe forceps, Knapp forceps, Chal more...
www.tawalthem.com | Send Inquiry | Phone: +92-(52)-3255829
FDA Registration: 3003407244 Employee Count: ~1970 Quality: ISO 9002, ISO 13488, CE Mark Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
T.A. Walthem & Company is a manufacturer and exporter of medical & surgical instruments. Our product line includes eye needle holders, lid retractors, iris forceps, Graefe forceps, Knapp forceps, Chal more...
K Plus International | Address: 61/22 Tariq Road Cantt, Sialkot, Punjab 51310, Pakistan
Phone: +92-(52)-4269583
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
K Plus International offers medical and surgical instruments. Our products include surgical instrument trays, surgical pliers, medical probes, surgical hammers, surgical orthopedic scissors, mouth gag more...
Phone: +92-(52)-4269583
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
K Plus International offers medical and surgical instruments. Our products include surgical instrument trays, surgical pliers, medical probes, surgical hammers, surgical orthopedic scissors, mouth gag more...
Sabri Industries | Address: Opposite Mission Hospital, Paris Road, Sialkot, Punjab 51310, Pakistan
www.nmsabri.com | Send Inquiry | Phone: +92-(52)-4274703, 4592318
FDA Registration: 3003905396 Quality: ISO 9001:2000 & ISO 13485:2003, CE Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Sabri Industries is a manufacturer and exporter of surgical & dental instruments. Our surgical instruments include sterilizing aids, scalpel handles, thermostatic forceps, needle holders, eye scissors more...
www.nmsabri.com | Send Inquiry | Phone: +92-(52)-4274703, 4592318
FDA Registration: 3003905396 Quality: ISO 9001:2000 & ISO 13485:2003, CE Certified
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Sabri Industries is a manufacturer and exporter of surgical & dental instruments. Our surgical instruments include sterilizing aids, scalpel handles, thermostatic forceps, needle holders, eye scissors more...
Aemco Z E (Pvt) Ltd | Address: Elahiabad, Wazirabad Road, Silakot, Punjab 51330, Pakistan
Send Inquiry | Phone: +92-(52)-4263222
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Aemco Z E (Pvt) Ltd is a supplier of cardiac catheterisation equipment, surgical instruments and endoscopes. We offer bone cutting forceps, otoscopes, orthopedic scissors, retractors, needle holders a more...
Send Inquiry | Phone: +92-(52)-4263222
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Aemco Z E (Pvt) Ltd is a supplier of cardiac catheterisation equipment, surgical instruments and endoscopes. We offer bone cutting forceps, otoscopes, orthopedic scissors, retractors, needle holders a more...
Concise Enterprises | Address: Mualim Para, Kotli Behram, Sialkot 51310, Pakistan
www.concise.com.pk | Send Inquiry | Phone: +92-(432)-270271, 260459
FDA Registration: 3003334541
Products: Stethoscopes, Tissue Forceps, Hammers, General Surgical Instruments, Forceps, Hemostatic, Surgical Instrument (Miscellaneous Medical), ...
Concise Enterprises manufactures surgical, dental, T.C pedicure, veterinary, orthodontics, hollow-wear and wide range of scissors & pliers. Our surgical instruments comprise of diagnostics, anesthesia more...
www.concise.com.pk | Send Inquiry | Phone: +92-(432)-270271, 260459
FDA Registration: 3003334541
Products: Stethoscopes, Tissue Forceps, Hammers, General Surgical Instruments, Forceps, Hemostatic, Surgical Instrument (Miscellaneous Medical), ...
Concise Enterprises manufactures surgical, dental, T.C pedicure, veterinary, orthodontics, hollow-wear and wide range of scissors & pliers. Our surgical instruments comprise of diagnostics, anesthesia more...
Mani, Inc. | Address: 743 Nakaakutsu, Shioya-gun, Takanezawa-Machi, Tochigi-Ken 329-1234, Japan
www.mani.co.jp | Send Inquiry | Phone: +81-(28)-675-3311
FDA Registration: 8030343 Year Established: 1959 Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Automatic Surgical Stapler (FDA Code: GAG), Disposable Suture Needle (FDA Code: GAB), General Surgical Manual Instrument (FDA Code: MDM), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Reusable Suture Needle (FDA Code: GDL), Ophthalmic Knife (FDA Code: HNN), ...
Mani, Inc. is a provider of surgical eyeless and eyed needles. Our products include micro eyeless surgical needles, skin staplers, ophthalmic sutures and ophthalmic knife. more...
www.mani.co.jp | Send Inquiry | Phone: +81-(28)-675-3311
FDA Registration: 8030343 Year Established: 1959 Employee Count: ~300 Quality: ISO 9001, CE Certified
Products: Automatic Surgical Stapler (FDA Code: GAG), Disposable Suture Needle (FDA Code: GAB), General Surgical Manual Instrument (FDA Code: MDM), Polyamide Synthetic Non-Absorbable Suture (FDA Code: GAR), Reusable Suture Needle (FDA Code: GDL), Ophthalmic Knife (FDA Code: HNN), ...
Mani, Inc. is a provider of surgical eyeless and eyed needles. Our products include micro eyeless surgical needles, skin staplers, ophthalmic sutures and ophthalmic knife. more...
Viia International | Address: 406, Amber Tower, Commercial Complex, Azadpur, Delhi, Delhi 110033, India 
www.viiainternational.com | Send Inquiry | Phone: +91-(11)-27673203/9810101569
Products: Bone Drills, Bone Holding Forceps, Bone Holding and Plate Holding Forceps, Austin Moore Pins, Bone Plates, DCP 3.5mm, Bone Plates, Cloverleaf, ...
Viia International manufactures orthopaedic implants, orthopaedic instruments, surgical instruments, walking aids, laboratory goods and medical disposables. We are engaged in importing scientific inst more...
www.viiainternational.com | Send Inquiry | Phone: +91-(11)-27673203/9810101569
Products: Bone Drills, Bone Holding Forceps, Bone Holding and Plate Holding Forceps, Austin Moore Pins, Bone Plates, DCP 3.5mm, Bone Plates, Cloverleaf, ...
Viia International manufactures orthopaedic implants, orthopaedic instruments, surgical instruments, walking aids, laboratory goods and medical disposables. We are engaged in importing scientific inst more...
Inor | Address: Plot No.2, Kanjur Village Road, Kanjur Marg (E), Mumbai, Maharashtra 400042, India
inor.bbtcl.com | Send Inquiry | Phone: +91-(22)-25785651, 25782852
Products: Clamps, Drills, Elevators, Retractors, Saws (FDA Code: HSO), Primary Shell/Cup Systems, ...
Inor manufactures and supplies dental products, opthalmics and orthopaedics. Our kalzinol is a rapid setting radiopaque zinc oxide/eugenol resin bonded material, which are ideal for sensitive cavities more...
inor.bbtcl.com | Send Inquiry | Phone: +91-(22)-25785651, 25782852
Products: Clamps, Drills, Elevators, Retractors, Saws (FDA Code: HSO), Primary Shell/Cup Systems, ...
Inor manufactures and supplies dental products, opthalmics and orthopaedics. Our kalzinol is a rapid setting radiopaque zinc oxide/eugenol resin bonded material, which are ideal for sensitive cavities more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Small Depth Gauge (FDA Code: HTJ), Depth Gauge (FDA Code: HTJ), Y-Stent Forceps, Guiding Probes, Flexible Depth Gauge (FDA Code: HTJ), ENT Forceps (FDA Code: KAE), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
Eurosurgical Germany Ltd. | Address: Forum Landsberger Allee, Landsberger, Allee 117a-9og, Berlin 10407, Germany 
Phone: +49-(30)-930-24115
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Eurosurgical Germany Ltd. manufactures medical surgical products. Our products include calipers, curettes, disposable surgical instrument kits, ENT irrigation syringes, plastic surgery surgical gouges more...
Phone: +49-(30)-930-24115
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Eurosurgical Germany Ltd. manufactures medical surgical products. Our products include calipers, curettes, disposable surgical instrument kits, ENT irrigation syringes, plastic surgery surgical gouges more...
ILG Medizintechnik Gmbh | Address: Dorfstrasse 2, Durchhausen 78591, Germany
www.ilg-medizintechnik.de | Send Inquiry | Phone: +49-(746)-3995411
FDA Registration: 9611610
Products: Saws (FDA Code: HSO), Saws Instruments, Instrument Holder, Ear Snare (FDA Code: JZD), Saw Handle, Suction Biopsy Instrument (FDA Code: FCK), ...
ILG Medizintechnik Gmbh specializes in the production of medical & surgical instruments. Our surgical instruments include biopsy suction devices, ENT snares, instrument holders, saw hand holds, suctio more...
www.ilg-medizintechnik.de | Send Inquiry | Phone: +49-(746)-3995411
FDA Registration: 9611610
Products: Saws (FDA Code: HSO), Saws Instruments, Instrument Holder, Ear Snare (FDA Code: JZD), Saw Handle, Suction Biopsy Instrument (FDA Code: FCK), ...
ILG Medizintechnik Gmbh specializes in the production of medical & surgical instruments. Our surgical instruments include biopsy suction devices, ENT snares, instrument holders, saw hand holds, suctio more...
W-Spine Gmbh | Address: Friedrich-Woehler-Str. 8, Emmingen-Liptingen 78576, Germany
www.w-spine.com | Send Inquiry | Phone: +49-(7465)-920-90-14
Quality: ISO 13485 Certified
Products: Bone Taps (FDA Code: HWX), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), General & Plastic Surgery Surgical Rasp (FDA Code: GAC), General Surgical Manual Instrument (FDA Code: MDM), Bender (FDA Code: HXW), Cement Dispenser (FDA Code: KIH), ...
W-Spine Gmbh is involved in the field of spine surgery. Our products include spongioplasty products, pedicle starter kit, dilator set and instruments. The spongioplastic technique is created on both s more...
www.w-spine.com | Send Inquiry | Phone: +49-(7465)-920-90-14
Quality: ISO 13485 Certified
Products: Bone Taps (FDA Code: HWX), General & Plastic Surgery Surgical Mallet (FDA Code: GFJ), General & Plastic Surgery Surgical Rasp (FDA Code: GAC), General Surgical Manual Instrument (FDA Code: MDM), Bender (FDA Code: HXW), Cement Dispenser (FDA Code: KIH), ...
W-Spine Gmbh is involved in the field of spine surgery. Our products include spongioplasty products, pedicle starter kit, dilator set and instruments. The spongioplastic technique is created on both s more...
Weber Instrumente GmbH & Co. KG | Address: Friedrich-Woehler-Strasse 8, Emmingen-Liptingen D-78576, Germany
www.weber-instrumente.com | Send Inquiry | Phone: +49-(7465)-9 20 90-0
FDA Registration: 8010916 Quality: ISO 13485 Certified
Products: Saws (FDA Code: HSO), Bone Taps (FDA Code: HWX), Wire Cutters (FDA Code: HXZ), Rib Rongeurs (FDA Code: HTX), General Surgical Scissors (FDA Code: LRW), Ruler and Caliper (FDA Code: FTY), ...
Weber Instrumente GmbH & Co. KG specializes in offering surgical instruments. Our products include softgrip handles, surgical instruments, mallets, modular spine instruments and special instruments. O more...
www.weber-instrumente.com | Send Inquiry | Phone: +49-(7465)-9 20 90-0
FDA Registration: 8010916 Quality: ISO 13485 Certified
Products: Saws (FDA Code: HSO), Bone Taps (FDA Code: HWX), Wire Cutters (FDA Code: HXZ), Rib Rongeurs (FDA Code: HTX), General Surgical Scissors (FDA Code: LRW), Ruler and Caliper (FDA Code: FTY), ...
Weber Instrumente GmbH & Co. KG specializes in offering surgical instruments. Our products include softgrip handles, surgical instruments, mallets, modular spine instruments and special instruments. O more...
Mahe-Barthelmes Medizintechnik Gmbh | Address: Friedrich Wohler Str 10, Emmingen-Liptingen 78576, Germany
www.mahemedical.net | Send Inquiry | Phone: +49-(7465)-9275-0
FDA Registration: 8010447 Quality: ISO 9001 Certified
Products: Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Y-Stent Forceps, ENT Forceps (FDA Code: KAE), Electrosurgical Electrode (FDA Code: JOS), ...
Mahe-Barthelmes Medizintechnik Gmbh provides medical equipment. We offer products for endoscopy, arthroscopy, ENT, laparoscopy and urology. The endoscopy products are insufflator 1400, purgorator 5100 more...
www.mahemedical.net | Send Inquiry | Phone: +49-(7465)-9275-0
FDA Registration: 8010447 Quality: ISO 9001 Certified
Products: Cosmetic Microsurgical Instruments, Titanium Microsurgical Instruments, Microsurgical Instruments (FDA Code: GZX), Y-Stent Forceps, ENT Forceps (FDA Code: KAE), Electrosurgical Electrode (FDA Code: JOS), ...
Mahe-Barthelmes Medizintechnik Gmbh provides medical equipment. We offer products for endoscopy, arthroscopy, ENT, laparoscopy and urology. The endoscopy products are insufflator 1400, purgorator 5100 more...
Rudolf Medical Gmbh + Co. Kg | Address: No. 1 Zollerstr, Fridingen 78567, Germany
www.rudolf-med.com | Phone: +49-(049)-7463-99560
FDA Registration: 8010298
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Rudolf Medical Gmbh + Co. Kg manufactures medical devices, equipments and instruments for open & minimally invasive surgery. The product lines for minimally invasive surgery instruments, endoscopes an more...
www.rudolf-med.com | Phone: +49-(049)-7463-99560
FDA Registration: 8010298
Products: Laser Power Probe, Laparoscopic Probes, Periodontal Probes, Medical Probes (FDA Code: HXB), Guiding Probes, Probes (FDA Code: HXB), ...
Rudolf Medical Gmbh + Co. Kg manufactures medical devices, equipments and instruments for open & minimally invasive surgery. The product lines for minimally invasive surgery instruments, endoscopes an more...
Seifring - Instrumente GmbH | Address: Gunninger Str. 35, Seitingen-Oberflacht 78606, Germany
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Vaginal Dilators (FDA Code: HDX), Rectal Speculums, Rectal Speculums (FDA Code: FFQ), ...
Seifring - Instrumente GmbH specializes in offering hemostatic clips. Our products include self-retaining retractors, vaginal dilators, bone cutting forceps, surgical hammer, bone holding forceps, abd more...
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Vaginal Dilators (FDA Code: HDX), Rectal Speculums, Rectal Speculums (FDA Code: FFQ), ...
Seifring - Instrumente GmbH specializes in offering hemostatic clips. Our products include self-retaining retractors, vaginal dilators, bone cutting forceps, surgical hammer, bone holding forceps, abd more...
Hammacher Instrumente Gmbh | Address: Steinendorfer Str. 27, Solingen 42699, Germany
www.hammacher.de | Send Inquiry | Phone: +49-(212)-262500
Annual Revenues: < USD 1 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Absorbable Suture Anchors, Absorbable Sutures (FDA Code: GAK), Adenoid Curettes (FDA Code: KBJ), Adenoid Punches (FDA Code: KBS), Absorbable Suture Screwed Anchor, Adult Tongue Depressor (FDA Code: FMA), ...
Hammacher Instrumente Gmbh is a manufacturer of stainless steel wironit instruments for dental, biological and medical laboratories. Our dental products include impression trays, whetstones, surgical more...
www.hammacher.de | Send Inquiry | Phone: +49-(212)-262500
Annual Revenues: < USD 1 Million Employee Count: ~30 Quality: ISO 9001, CE Certified
Products: Absorbable Suture Anchors, Absorbable Sutures (FDA Code: GAK), Adenoid Curettes (FDA Code: KBJ), Adenoid Punches (FDA Code: KBS), Absorbable Suture Screwed Anchor, Adult Tongue Depressor (FDA Code: FMA), ...
Hammacher Instrumente Gmbh is a manufacturer of stainless steel wironit instruments for dental, biological and medical laboratories. Our dental products include impression trays, whetstones, surgical more...
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FDA Code / Regulation: HSO / 878.4800
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9.
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