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 Implant, Eye Valve
510(k) Number K903462
Device Name OPTIMED GLAUCOMA PRESSURE REGULATOR
Applicant
Optimed, Inc.
126 Power Ave.
Santa Barbara,  CA  93103
Applicant Contact MYRON LIPPMAN
Correspondent
Optimed, Inc.
126 Power Ave.
Santa Barbara,  CA  93103
Correspondent Contact MYRON LIPPMAN
Regulation Number886.3920
Classification Product Code
KYF  
Date Received08/01/1990
Decision Date 10/16/1990
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
-
-