Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Needle, Ophthalmic Suturing
510(k) Number K844448
Device Name OMS/GONVERS RETINAL PERFORATOR
Applicant
Optical Micro Systems, Inc.
8 Electronics Ave.
Danvers,  MA  01923
Applicant Contact GERALD A CLAY
Correspondent
Optical Micro Systems, Inc.
8 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact GERALD A CLAY
Regulation Number886.4350
Classification Product Code
HNM  
Date Received11/16/1984
Decision Date 08/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-