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 K935974
Device Name SPECTACLE FRAMES AND SUNGLASSES
Applicant
Pan Oceanic Eyewear
15 W. 37 St.
New York,  NY  10018
Applicant Contact LEO ESSES
Correspondent
Pan Oceanic Eyewear
15 W. 37 St.
New York,  NY  10018
Correspondent Contact LEO ESSES
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/13/1993
Decision Date 04/06/1994
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
-
-