Speculum Accessories Suppliers
Limit companies to: Worldwide USA
Medtronic Xomed Surgical Products, Inc | Address: 6743 Southpoint Drive North, Jacksonville, Florida 32216-0980, USA 
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
www.xomed.com | Phone: +1-(904)-296-9600, 800-874-5797
FDA Registration: 1045254 Year Established: 1999 Annual Revenues: USD 500 Million to 1 Billion Employee Count: ~650 Quality: ISO 9001, CE Certified
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Sinus Trochars and Cannulae, Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Navigation Interface/Display, ...
Medtronic Xomed Surgical Products, Inc develops products that treat people with ear, nose and throat (ENT) diseases. our products include MeroPack®, Bioresorbable Nasal Dressing and Sinus Stent, I more...
Boss Instruments, Ltd. | Address: 395 Reas Ford Road, Suite 120, Earlysville, Virginia 22936, USA
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Tissue Forceps, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
www.bossinst.com | Send Inquiry | Phone: +1-(800)-210-2677
FDA Registration: 1056350 Year Established: 1990 Annual Revenues: < USD 1 Million Employee Count: ~10 Quality: ISO 9000, ISO 9002, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Retractors, Saws (FDA Code: HSO), Tissue Forceps, ...
Boss Instruments, Ltd. is a surgical instrument company which concentrates on the manufacture and continual development of specialty lines of instruments include ear, nose, and throat, general surgery more...
R Medical Inc. | Address: 28835 N. Herky Drive, Unit 101, Lake Bluff, Illinois 60044, USA
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
r-medicalinc.com | Send Inquiry | Phone: +1-(847)-816 1615
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
R Medical Inc. provides instruments & equipment for both open surgery & for endoscopy. We specialize in Easy-port® trocars, the Rudolf laparoscopy system instruments with cameras and light sources more...
Instrumed International, Inc. | Address: 626 Cooper Court, Schaumburg, Illinois 60173, USA
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Vaginal Retractors (FDA Code: HDL), Micro Surgery Instruments, Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Retractor System, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
www.instrumedinc.biz | Phone: +1-(847)-908-0292
FDA Registration: 1421101
Products: Laparoscopic Equipment, Vaginal Retractors (FDA Code: HDL), Micro Surgery Instruments, Bipolar Forceps, Gastroenterologic Needle Holder (FDA Code: FHQ), Retractor System, ...
Instrumed International, Inc. specializes in providing reusable surgical instruments. We offer surgical products for bipolar, CV/thoracic, ENT, general, hand & micro surgery, laparoscopic, laryngeal, more...
Ulrich Medical. | Address: 54 Spirit 40 Park Drive, Chesterfield, Missouri 63005, USA
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
www.ulrichmedical.com | Send Inquiry | Phone: +1-(866)-519-0268
FDA Registration: 9612420
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Ankle Distractors, General Surgical Instruments, ...
Ulrich Medical specializes in providing spiral implants, tourniquets, surgical instruments and family of cages products. Our Cosmic™ system provides stabilized suspension of the spinal segments a more...
Pedia Pals LLC | Address: 230 Grider St., Buffalo, New York 14215, USA
www.pediapals.com | Send Inquiry | Phone: +1-(888)-733-427
Products: Calipers, Exam Tables, Hammers, General Medical Supplies, Ophthalmoscope Aids, Otoscope Aids, ...
Pedia Pals, LLC designs, manufactures and markets pediatric medical equipment & supplies. Our exam tables, room decal kits and accessories help to deliver high quality heath care. Our Pedia Pals Jamaa more...
www.pediapals.com | Send Inquiry | Phone: +1-(888)-733-427
Products: Calipers, Exam Tables, Hammers, General Medical Supplies, Ophthalmoscope Aids, Otoscope Aids, ...
Pedia Pals, LLC designs, manufactures and markets pediatric medical equipment & supplies. Our exam tables, room decal kits and accessories help to deliver high quality heath care. Our Pedia Pals Jamaa more...
Electro Surgical Instrument Co., Inc. | Address: 37 Centennial St., Rochester, New York 14611, USA
www.electrosurgicalinstrument.com | Send Inquiry | Phone: +1-(585)-235-1430, 888-464-2784
FDA Registration: 1315756 Year Established: 1896 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Vaginal Retractors (FDA Code: HDL), Self-Retaining Retractors (FDA Code: FFO), Tongue Depressors (FDA Code: FMA), Flavored Tongue Depressors, Sweetened Tongue Depressors, Used Tongue Depressors, ...
Electro Surgical Instrument Co., Inc.is a manufacturer of lighted medical instruments. Our products include lighting system components, neurosurgical instruments, nasal instruments, transilluminators, more...
www.electrosurgicalinstrument.com | Send Inquiry | Phone: +1-(585)-235-1430, 888-464-2784
FDA Registration: 1315756 Year Established: 1896 Annual Revenues: < USD 1 Million Quality: ISO Certified
Products: Vaginal Retractors (FDA Code: HDL), Self-Retaining Retractors (FDA Code: FFO), Tongue Depressors (FDA Code: FMA), Flavored Tongue Depressors, Sweetened Tongue Depressors, Used Tongue Depressors, ...
Electro Surgical Instrument Co., Inc.is a manufacturer of lighted medical instruments. Our products include lighting system components, neurosurgical instruments, nasal instruments, transilluminators, more...
Hospital & Homecare Imp. & Exp. Co., Ltd. | Address: Room 608-611, No.5 Zhongtai Int. Plaza, No.311 Middle of Jiangdong Rd, Central Business Dist, Nanjing, Jiangsu, China 
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
Kronring HB | Address: Skalby Gard, Vasteras 72476, Sweden
Phone: +46-(21)-352-555
Year Established: 1895 Annual Revenues: < USD 1 Million Employee Count: ~30
Products: Blood Lancets, Face Masks, Cytology Brushes, Aprons, Jars, Test Tubes, ...
Kronring HB specializes in offering various medical devices such as surgical accessories, optical aids, trays, operating equipment and endodontic instruments. We also offer accessories for dental equi more...
Phone: +46-(21)-352-555
Year Established: 1895 Annual Revenues: < USD 1 Million Employee Count: ~30
Products: Blood Lancets, Face Masks, Cytology Brushes, Aprons, Jars, Test Tubes, ...
Kronring HB specializes in offering various medical devices such as surgical accessories, optical aids, trays, operating equipment and endodontic instruments. We also offer accessories for dental equi more...
Combined Instruments (Pvt.), Ltd. | Address: 13-A Model Town, Ugoki, Sailkot, Pakistan
Phone: +92-(432)-510243
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
Phone: +92-(432)-510243
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, ...
Combined Instruments (Pvt.), Ltd. is a manufacturer and exporter of general surgery instruments. Our products include cotton applicators, scalpel blades, depth gauge, ear speculum holders, biopsy & su more...
Clinical Surgical | Address: P.O. Gohad Pur, Near Islamia Girls High, School, Sialkot, PK-PB 51310, Pakistan
www.clinicalsurgical.com | Send Inquiry | Phone: +92-(52)-4292262
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), ...
Clinical Surgical manufactures surgical and dental instruments. Our surgical instruments include diagnostics, anesthesia, puncture, scalpels,scissors, knives, dressing & tissue forceps, sponge and sut more...
www.clinicalsurgical.com | Send Inquiry | Phone: +92-(52)-4292262
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), ...
Clinical Surgical manufactures surgical and dental instruments. Our surgical instruments include diagnostics, anesthesia, puncture, scalpels,scissors, knives, dressing & tissue forceps, sponge and sut more...
Goval Internacional S.A. De C.V. | Address: Washington 3000 Pte., Col. Deportivo Obispado, Monterrey, MX-NLE 64040, Mexico
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), ...
Goval Internacional S.A. De C.V. is a provider of surgical and diagnostic equipments. more...
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Surgical Retractor Systems (FDA Code: GAD), Lacrimal Dilator (FDA Code: HNW), ...
Goval Internacional S.A. De C.V. is a provider of surgical and diagnostic equipments. 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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
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...
Kirchner & Wilhelm GmbH & Co. KG Medizintechnik | Address: Eberhardstr 56, Asperg 71679, Germany 
www.kawemed.de | Send Inquiry | Phone: +49-(7141)-68-188-0
FDA Registration: 8010427 Year Established: 1890 Employee Count: ~50 Quality: ISO: 9001, ISO: 13485, CE Certified
Products: Cotton Swabs, Percussion Hammer, Alcohol Swabstick, Sterile Cotton Swabs, Surgical Tables Accessories, Infusion Stand, Infusion Stand (FDA Code: FOX), ...
Kirchner & Wilhelm GmbH & Co. KG Medizintechnik specializes in medical products under the categories such as otoscopes, opthalmoscopes, tuning forks, lamps, and blood pressure measuring devices. The M more...
www.kawemed.de | Send Inquiry | Phone: +49-(7141)-68-188-0
FDA Registration: 8010427 Year Established: 1890 Employee Count: ~50 Quality: ISO: 9001, ISO: 13485, CE Certified
Products: Cotton Swabs, Percussion Hammer, Alcohol Swabstick, Sterile Cotton Swabs, Surgical Tables Accessories, Infusion Stand, Infusion Stand (FDA Code: FOX), ...
Kirchner & Wilhelm GmbH & Co. KG Medizintechnik specializes in medical products under the categories such as otoscopes, opthalmoscopes, tuning forks, lamps, and blood pressure measuring devices. The M more...
Rebstock Instruments GmbH | Address: In Weiheräcker 7, Dürbheim - Tuttlingen D-78589, Germany
www.rebstock-germany.de | Send Inquiry | Phone: +49-(7424)-6734
FDA Registration: 9681161
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Bone Clamp (FDA Code: HXD), Rib Rongeurs (FDA Code: HTX), ENT Forceps (FDA Code: KAE), ...
Rebstock Instruments GmbH specializes in offering products for the physicians and patients all over the world. We offer products for neurosurgery, spine, microsurgery, general surgery, cardiovascular, more...
www.rebstock-germany.de | Send Inquiry | Phone: +49-(7424)-6734
FDA Registration: 9681161
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Surgical Retractor Systems (FDA Code: GAD), Scalpel Handle (FDA Code: GDZ), Bone Clamp (FDA Code: HXD), Rib Rongeurs (FDA Code: HTX), ENT Forceps (FDA Code: KAE), ...
Rebstock Instruments GmbH specializes in offering products for the physicians and patients all over the world. We offer products for neurosurgery, spine, microsurgery, general surgery, cardiovascular, 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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
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: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
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...
Heinz Herenz Medizinalbedarf GmbH | Address: Rudorffweg 10, Hamburg D-21031, Germany
www.herenz.de | Send Inquiry | Phone: +49-(40)-739204
Year Established: 1949 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: DIN EN ISO 13485:2003, CE Mark Certified
Products: Blood Lancets, Face Masks, Cytology Brushes, Aprons, Jars, Test Tubes, ...
Heinz Herenz Medizinalbedarf GmbH is a manufacturer and wholesaler of laboratory & medical supplies. Our main products are disposables for lab & hospital supplies, laboratory glassware, blood lancets, more...
www.herenz.de | Send Inquiry | Phone: +49-(40)-739204
Year Established: 1949 Annual Revenues: USD 5-10 Million Employee Count: ~20 Quality: DIN EN ISO 13485:2003, CE Mark Certified
Products: Blood Lancets, Face Masks, Cytology Brushes, Aprons, Jars, Test Tubes, ...
Heinz Herenz Medizinalbedarf GmbH is a manufacturer and wholesaler of laboratory & medical supplies. Our main products are disposables for lab & hospital supplies, laboratory glassware, blood lancets, 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: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Double Prong Skin Hooks, Single Prong Skin Hooks, ...
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: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Double Prong Skin Hooks, Single Prong Skin Hooks, ...
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...
Instrumed GmbH | Address: 3 Unter Buchsteig, Tuttlingen 78532, Germany
Phone: +49-(7462)-20049-126
FDA Registration: 8010372 Employee Count: ~10
Products: Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Instrumed GmbH deals with vaginal retractors, self-retaining retractors, ophthalmic rings, ronguers, ENT knives and hemostats. more...
Phone: +49-(7462)-20049-126
FDA Registration: 8010372 Employee Count: ~10
Products: Vaginal Retractors (FDA Code: HDL), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Instrumed GmbH deals with vaginal retractors, self-retaining retractors, ophthalmic rings, ronguers, ENT knives and hemostats. more...
Gebrüder Martin GmbH & Co. KG, | Address: Ludwigstaler Str 132, Tuttlingen 78532, Germany
www.martin-med.com | Phone: +49-(7461)-706-343
FDA Registration: 8010168 Annual Revenues: < USD 1 Million Employee Count: ~700 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Gebrüder Martin GmbH & Co. KG, specializes in surgical products. Our products include surgical instruments, examination lights, & medical camera systems. Our surgical instruments are used in electrosu more...
www.martin-med.com | Phone: +49-(7461)-706-343
FDA Registration: 8010168 Annual Revenues: < USD 1 Million Employee Count: ~700 Quality: ISO 9001, CE Certified
Products: Vaginal Retractors (FDA Code: HDL), Blood Lancets, Forceps (FDA Code: HTD), Double Prong Skin Hooks, Single Prong Skin Hooks, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Gebrüder Martin GmbH & Co. KG, specializes in surgical products. Our products include surgical instruments, examination lights, & medical camera systems. Our surgical instruments are used in electrosu more...
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FDA Code / Regulation: FXG / 878.1800
A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.
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.
