FDA.reportPublic FDA data

510(k) K844448

Device
OMS/GONVERS RETINAL PERFORATOR
Applicant
OPTICAL MICRO SYSTEMS, INC.
510(k) number
K844448
Product code
HNM  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-21
Date received
1984-11-16
Regulation
886.4350
Classification name
Needle, Ophthalmic Suturing
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GERALD A CLAY
Address
8 Electronics Ave. Danvers MA US 01923 01923

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HNM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K780154NEEDLEHOLDER, MICROVASULAR 5 1/2Edward Weck, Inc.1978-03-17

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases