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 Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K901299
Device Name CELEBRITY-CARENZA-SUNGEAR-SUMMIT SUNGLASSES
Applicant
Sun Mark, Inc.
P.O. Box 115032
Carrollton,  TX  75011
Applicant Contact ROBERT HOWARD
Correspondent
Sun Mark, Inc.
P.O. Box 115032
Carrollton,  TX  75011
Correspondent Contact ROBERT HOWARD
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/20/1990
Decision Date 05/15/1990
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
-
-