Bone Clamp Suppliers
Limit companies to: Worldwide USA
UNS Instruments | Address: 19/535 Green Wood Street, Sialkot 51310, Pakistan
www.unsinstruments.com | Send Inquiry | Phone: +92-(333)-8698488
Products: Stethoscopes, Laryngoscopes, Bone Holding Forceps, Biopsy Forceps, Nail Nippers & Trimmers, Percussion Hammer, ...
UNS Instruments manufactures and exports beauty, dental & surgical instruments & scissors of all sorts. Our products include laryngoscopes, anaesthetic inhalers, catheter forceps, scalpel handles, bon more...
www.unsinstruments.com | Send Inquiry | Phone: +92-(333)-8698488
Products: Stethoscopes, Laryngoscopes, Bone Holding Forceps, Biopsy Forceps, Nail Nippers & Trimmers, Percussion Hammer, ...
UNS Instruments manufactures and exports beauty, dental & surgical instruments & scissors of all sorts. Our products include laryngoscopes, anaesthetic inhalers, catheter forceps, scalpel handles, bon more...
A.N.A Amity Impex | Address: A.N.A Square, Airport Road, Muradpur, Sialkot 51310, Pakistan
www.anaamity.com | Send Inquiry | Phone: +92-(52)-4268654
Quality: ISO-9001 Certified
Products: Elevators, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Scalpels, ...
A.N.A Amity Impex is a manufacturer and exporter of surgical, dental, veterinary, manicure & pedicure implements. We are an ISO 9001:2000, pGMP and CE certified company. Our surgical instruments inclu more...
www.anaamity.com | Send Inquiry | Phone: +92-(52)-4268654
Quality: ISO-9001 Certified
Products: Elevators, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Scalpels, ...
A.N.A Amity Impex is a manufacturer and exporter of surgical, dental, veterinary, manicure & pedicure implements. We are an ISO 9001:2000, pGMP and CE certified company. Our surgical instruments inclu more...
Chand Jee Mfg.Co. | Address: Jinnah Islamia College Road, P.O.Box: 1255, Sialkot, Pakistan
www.chandjee.com.pk | Send Inquiry | Phone: +92-(432)-580589
Annual Revenues: USD 1-5 Million Employee Count: ~80 Quality: ISO 9001 Certified
Products: Clamps, Forceps (FDA Code: HTD), Dressing Forceps, Vascular Clamps (FDA Code: DXC), Balloon Ureteral Dilators, Surgical Retractor Systems (FDA Code: GAD), ...
Chand Jee Mfg.Co. manufactures and exports surgical & dental instruments, scissors & pliers of all sorts. We are accredited with ISO 9000-2000 certification. Our products are CE marked. Our product li more...
www.chandjee.com.pk | Send Inquiry | Phone: +92-(432)-580589
Annual Revenues: USD 1-5 Million Employee Count: ~80 Quality: ISO 9001 Certified
Products: Clamps, Forceps (FDA Code: HTD), Dressing Forceps, Vascular Clamps (FDA Code: DXC), Balloon Ureteral Dilators, Surgical Retractor Systems (FDA Code: GAD), ...
Chand Jee Mfg.Co. manufactures and exports surgical & dental instruments, scissors & pliers of all sorts. We are accredited with ISO 9000-2000 certification. Our products are CE marked. Our product li more...
Accompany Surgical (Pvt) Ltd. | Address: Vill. Dhattal, Ugoki Road, Sialkot 51310, Pakistan
Send Inquiry | Phone: +92-(52)-3512679
FDA Registration: 8041151
Products: Forceps (FDA Code: HTD), Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), Bone Clamp (FDA Code: HXD), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Metal Vaginal Speculum (FDA Code: HDF), ...
Accompany Surgical (Pvt) Ltd. specializes in vaginal speculum, dental carvers & hand instruments, scissors & hand instruments, scalers and scalpel handles. more...
Send Inquiry | Phone: +92-(52)-3512679
FDA Registration: 8041151
Products: Forceps (FDA Code: HTD), Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), Bone Clamp (FDA Code: HXD), General & Plastic Surgery Surgical Spatula (FDA Code: GAF), Metal Vaginal Speculum (FDA Code: HDF), ...
Accompany Surgical (Pvt) Ltd. specializes in vaginal speculum, dental carvers & hand instruments, scissors & hand instruments, scalers and scalpel handles. more...
Hobri International | Address: Defence Road , Fateh Garh, Sialkot 51350, Pakistan
www.hobri.com | Phone: +92-(52)-355-0933
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Scalpel Handle (FDA Code: GDZ), Uterine Sounds (FDA Code: HHM), ENT Syringe (FDA Code: KCP), Bone Clamp (FDA Code: HXD), ...
Hobri International produces ranges of surgical & medical instruments, dental instruments, dissection instruments, manicure, pedicure products and cuticle products. more...
www.hobri.com | Phone: +92-(52)-355-0933
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Scalpel Handle (FDA Code: GDZ), Uterine Sounds (FDA Code: HHM), ENT Syringe (FDA Code: KCP), Bone Clamp (FDA Code: HXD), ...
Hobri International produces ranges of surgical & medical instruments, dental instruments, dissection instruments, manicure, pedicure products and cuticle products. more...
Silver Plus Corp. | Address: Mohammad Pura, Sialkot 22161, Pakistan
Phone: +92-(432)-593-360
FDA Registration: 9614075
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Silver Plus Corp. offers currettes, clamps, pinwheels, and retractors. more...
Phone: +92-(432)-593-360
FDA Registration: 9614075
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, ...
Silver Plus Corp. offers currettes, clamps, pinwheels, and retractors. more...
Win Wings Corp. | Address: 4 Small Industries Estates, Sialkot 22161, Pakistan
Phone: +92-(432)-256302
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Win Wings Corp. is associated with curettes, dilators, general & plastic surgery forceps, metal speculum, and surgical hammers. more...
Phone: +92-(432)-256302
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Surgical Trays (FDA Code: LRP), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Win Wings Corp. is associated with curettes, dilators, general & plastic surgery forceps, metal speculum, and surgical hammers. more...
DAR Expo | Address: 146-C, Fatima Jinnah Rd,Small Industrial Estate, Sialkot 51340, Pakistan
www.brain.net.pk/~zumar | Send Inquiry | Phone: +92-(432)-550702
Annual Revenues: < USD 1 Million Employee Count: ~40
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, ...
DAR Expo manufactures surgical and dental instruments. Our product area includes manicure instruments, surgical instruments, dental instruments and veterinary instruments. Our surgical instruments inc more...
www.brain.net.pk/~zumar | Send Inquiry | Phone: +92-(432)-550702
Annual Revenues: < USD 1 Million Employee Count: ~40
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Forceps Needle Holders, Stainless Steel Needle Holders, Tungsten Carbide Needle Holders, Micro Needle Holder, Hexagonal Needle Holder, ...
DAR Expo manufactures surgical and dental instruments. Our product area includes manicure instruments, surgical instruments, dental instruments and veterinary instruments. Our surgical instruments inc more...
Precision Surgical Works | Address: E-35/2a, Street No-3, Farooq Colony, Walton Rd., Lahore, PK-PB, Pakistan
precisionsurgicalworks.com | Send Inquiry | Phone: +92-(42)-5810678
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), ...
Precision Surgical Works is a manufacturer and exporter of eye & micro-surgery instruments. Our product line includes needle holders, micro forceps, high precision tweezers, hooks, probes, dilators, s more...
precisionsurgicalworks.com | Send Inquiry | Phone: +92-(42)-5810678
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), ...
Precision Surgical Works is a manufacturer and exporter of eye & micro-surgery instruments. Our product line includes needle holders, micro forceps, high precision tweezers, hooks, probes, dilators, s more...
Oraltech Instruments (Pvt) Ltd. | Address: Po Box #1600, Khan Villa, Cheema St Model Town, Sialkot, PK-PB 51310, Pakistan
Send Inquiry | Phone: +92-(52)-3555242
Quality: ISO 9001:2000 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), ...
Oraltech Instruments (pvt) Ltd. is a manufacturer of dental and surgical instruments. Our product line includes extracting forceps, root elevators, orthodontic pliers, filling instruments, bone curett more...
Send Inquiry | Phone: +92-(52)-3555242
Quality: ISO 9001:2000 Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Bone Mallets (FDA Code: HXL), ...
Oraltech Instruments (pvt) Ltd. is a manufacturer of dental and surgical instruments. Our product line includes extracting forceps, root elevators, orthodontic pliers, filling instruments, bone curett more...
The Mughal Surgical (Pvt) Ltd | Address: C-95 Industrial Estate, P.O.Box 274, Punjab Province, Sialkot, Punjab 51340, Pakistan
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Surgical Retractor Systems (FDA Code: GAD), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Surgical Retractor Systems (FDA Code: GAD), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
Medisporex (Pvt) Ltd. | Address: Khadim Ali Rd., P.O. Box 600, Sialkot, Punjab 51310, Pakistan
www.medisporex.com.pk | Send Inquiry | Phone: +92-(52)-3554148, 3553658, 325571
FDA Registration: 8040881
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Surgical Trays (FDA Code: LRP), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Medisporex (Pvt) Ltd. manufactures surgical instruments, dental instruments, veterinary instruments and hollow ware. Our surgical instruments include operating scissors, hemostatic forceps, retractors more...
www.medisporex.com.pk | Send Inquiry | Phone: +92-(52)-3554148, 3553658, 325571
FDA Registration: 8040881
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Surgical Trays (FDA Code: LRP), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Medisporex (Pvt) Ltd. manufactures surgical instruments, dental instruments, veterinary instruments and hollow ware. Our surgical instruments include operating scissors, hemostatic forceps, retractors more...
Hilbro Instruments (Pvt) Ltd. | Address: Small Indus. Estate, Sialkot, Punjab 51310, Pakistan
Phone: +92-(43)-2550922
FDA Registration: 9611062
Products: Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Wire Cutters (FDA Code: HXZ), Bone Clamp (FDA Code: HXD), Rib Rongeurs (FDA Code: HTX), Ophthalmic Suture Scissors (FDA Code: HNF), ...
Hilbro Instruments (Pvt) Ltd. is a manufacturer of fiber optic laryngoscopes. more...
Phone: +92-(43)-2550922
FDA Registration: 9611062
Products: Wire Twisters (FDA Code: HXS), Surgical Retractor Systems (FDA Code: GAD), Wire Cutters (FDA Code: HXZ), Bone Clamp (FDA Code: HXD), Rib Rongeurs (FDA Code: HTX), Ophthalmic Suture Scissors (FDA Code: HNF), ...
Hilbro Instruments (Pvt) Ltd. is a manufacturer of fiber optic laryngoscopes. more...
Hilbro International (Pvt) Limited | Address: Hilbro Industrial Park, 12 km, Daska Road, Sialkot, Punjab 51040, Pakistan
w3.hilbro.net | Send Inquiry | Phone: +92-(52)-6526881, 6526882
FDA Registration: 3003431869 Quality: ISO-9002/13485, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), ...
Hilbro International (Pvt) Limited is a manufacturer of surgical and dental instruments. We offer products for diagnostics, anesthesia, bone surgery, neuro surgery, tracheotomy, cardiovascular, goitre more...
w3.hilbro.net | Send Inquiry | Phone: +92-(52)-6526881, 6526882
FDA Registration: 3003431869 Quality: ISO-9002/13485, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Bone Rasps (FDA Code: HTR), ...
Hilbro International (Pvt) Limited is a manufacturer of surgical and dental instruments. We offer products for diagnostics, anesthesia, bone surgery, neuro surgery, tracheotomy, cardiovascular, goitre more...
Cardic Instruments | Address: P.O.Box: 147 Nishat Park, Opposite Sialkot Chamber, Sialkot, Punjab 51310, Pakistan
www.cardic.com.pk | Send Inquiry | Phone: +92-(52)-426 7708
Year Established: 1981 Quality: ISO 9001-2000, ISO-13485-2003, CE Mark, cGMP Certified
Products: Forceps (FDA Code: HTD), Bone Clamp (FDA Code: HXD), Surgical Orthopedic Scissors (FDA Code: HRR), ...
Cardic Instruments specialize in the manufacture of surgical, dental and beauty care instruments. Our products include cardiovascular instruments, tungsten carbide scissors, dissecting forceps, needle more...
www.cardic.com.pk | Send Inquiry | Phone: +92-(52)-426 7708
Year Established: 1981 Quality: ISO 9001-2000, ISO-13485-2003, CE Mark, cGMP Certified
Products: Forceps (FDA Code: HTD), Bone Clamp (FDA Code: HXD), Surgical Orthopedic Scissors (FDA Code: HRR), ...
Cardic Instruments specialize in the manufacture of surgical, dental and beauty care instruments. Our products include cardiovascular instruments, tungsten carbide scissors, dissecting forceps, needle 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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), ENT Syringe (FDA Code: KCP), ...
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: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), ENT Syringe (FDA Code: KCP), ...
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...
Technimen Skillers | Address: Small Indus Estate, Sialkot, Punjab 51340, Pakistan
Phone: +92-(523)-561772
FDA Registration: 3001620590
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Scalpel Handle (FDA Code: GDZ), Ligature Carrier Set (FDA Code: GEJ), ...
Technimen Skillers is a manufacturer of air conduction hearing aids, blood collection lancets, general & plastic surgery forceps, ophthalmic headband mirrors, arm slings, ear suction tubes, scalpel ha more...
Phone: +92-(523)-561772
FDA Registration: 3001620590
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Scalpel Handle (FDA Code: GDZ), Ligature Carrier Set (FDA Code: GEJ), ...
Technimen Skillers is a manufacturer of air conduction hearing aids, blood collection lancets, general & plastic surgery forceps, ophthalmic headband mirrors, arm slings, ear suction tubes, scalpel ha more...
Jimco Industries | Address: Chah Jattan Road., Sialkot, Punjab 51310, Pakistan
www.jimcoind.com | Phone: +92-(52)-4586496
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Suction Tubes, Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), Suction Equipment, Cannulae, ...
Jimco Industries manufactures surgical products. Our surgical products include scalpels, scissors, artery forceps, forceps, sutures, dressings, retractors, probes, trocar, suction tubes, suction cannu more...
www.jimcoind.com | Phone: +92-(52)-4586496
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Suction Tubes, Scalpel Handle (FDA Code: GDZ), Mouth Gags (FDA Code: KBN), Suction Equipment, Cannulae, ...
Jimco Industries manufactures surgical products. Our surgical products include scalpels, scissors, artery forceps, forceps, sutures, dressings, retractors, probes, trocar, suction tubes, suction cannu more...
Landen Tools Inc. | Address: Khan Street Amanat Pura, Jammu Road, Sialkot, Punjab 51310, Pakistan
www.landentools.com | Send Inquiry | Phone: +92-(52)-4581319
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), ...
Landen Tools Inc. specializes in producing custom medical and beauty tools. Our medical products include anesthesia instruments, diagnostic instruments, forceps and general instruments. We offer medic more...
www.landentools.com | Send Inquiry | Phone: +92-(52)-4581319
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Lacrimal Probes (FDA Code: HNL), Tongue Depressors (FDA Code: FMA), Surgical Retractor Systems (FDA Code: GAD), ...
Landen Tools Inc. specializes in producing custom medical and beauty tools. Our medical products include anesthesia instruments, diagnostic instruments, forceps and general instruments. We offer medic more...
Technimen Agha (pvt) Ltd | Address: Tecnimen Agha (pvt) Ltd, Kashmir Road, Sialkot, Punjab 51310, Pakistan
www.technimen.com | Send Inquiry | Phone: +92-(52)-4263834
FDA Registration: 3007057998
Products: Gynecology Instruments, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Scissors, Sutures, ...
Technimen Agha (pvt) Ltd focuses on surgical instruments. Our surgical products include scalpel handles, scissors, artery forceps, retractors, probes, applicators, spatulas, suture, bone surgery produ more...
www.technimen.com | Send Inquiry | Phone: +92-(52)-4263834
FDA Registration: 3007057998
Products: Gynecology Instruments, Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Scissors, Sutures, ...
Technimen Agha (pvt) Ltd focuses on surgical instruments. Our surgical products include scalpel handles, scissors, artery forceps, retractors, probes, applicators, spatulas, suture, bone surgery produ more...
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FDA Code / Regulation: HXD / 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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