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 Frame, Spectacle
510(k) Number K922930
Device Name OPTICAL FRAMES
Applicant
St. Germain Eyewear Intl.
1126 Via Arroyo Ct.
Ventura,  CA  93003
Applicant Contact TIMOTHY R RAKE
Correspondent
St. Germain Eyewear Intl.
1126 Via Arroyo Ct.
Ventura,  CA  93003
Correspondent Contact TIMOTHY R RAKE
Regulation Number886.5842
Classification Product Code
HQZ  
Date Received06/17/1992
Decision Date 09/17/1992
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
-
-