37-940 to 37-944 Various Noyes Ophthalmic Forceps

FDA 510(k) K851792 · Artiberia

Substantially Equivalent

510(k) numberK851792

Submission

Device name
37-940 to 37-944 Various Noyes Ophthalmic Forceps
Applicant
Artiberia
San Antonio, TX, US
Received
April 25, 1985
Decision date
May 30, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HNR – Forceps, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.4350
Specialty
Ophthalmic

Other 510(k)s with product code HNR

510(k)DeviceApplicantDecision
K022835Stephens Disposable ForcepsHNR · Traditional Stephens Instruments11/01/2002SE
K895434Alcon Folding ForcepsHNR · Traditional Alcon Laboratories12/04/1989SE
K891487Soft Lens Folding BlockHNR · Traditional Western Medical Products, Inc.08/15/1989SE
K893199Phaco-Injector(Tm) Intraocular Lens Implant InstrHNR · Traditional Allergan Medical Optics06/16/1989SE
K885230Mcdonald Folding ForcepsHNR · Traditional Alcon Laboratories05/17/1989SE
K881049Bradbury Intraocular Retinal Kit Cat #200HNR · Traditional Microline Pentax, Inc.09/12/1988SE
K883197Iol Implantation ForcepsHNR · Traditional D & D Surgical08/22/1988SE
K880274Advanced Surgical Products Scleral Plug ForcepsHNR · Traditional Advanced Surgical Products, Inc.02/05/1988SE
K864266Ophthalmic Knife & ForcepsHNR · Traditional Western Medical Products, Inc.11/28/1986SE
K864183Ophthalmic Surgical InstrumentsHNR · Traditional Techno Ophthalmics Intl.11/28/1986SE

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Questions and answers

When was 37-940 to 37-944 Various Noyes Ophthalmic Forceps cleared by the FDA?

37-940 to 37-944 Various Noyes Ophthalmic Forceps (K851792) received a 510(k) decision of Substantially Equivalent on May 30, 1985, 35 days after the submission was received.

What is the product code of K851792?

The FDA product code is HNR – Forceps, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.