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 Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
510(k) Number K914095
Device Name PEEPERS TANNING GOGGLES
Applicant
California Suncare, Inc.
1100 Glendon Ave.
Suite 1250
Los Angeles,  CA  90024
Applicant Contact DONALD J CHRISTAL
Correspondent
California Suncare, Inc.
1100 Glendon Ave.
Suite 1250
Los Angeles,  CA  90024
Correspondent Contact DONALD J CHRISTAL
Regulation Number886.4750
Classification Product Code
HOY  
Date Received09/12/1991
Decision Date 10/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-