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 K931254
Device Name GOGGLE SAFEGUARD
Applicant
Sellstrom Mfg. Co.
Sellstrom Industrial Park
One Sellstrom Dr.
Palatine,  IL  60067
Applicant Contact LORI BUTLER
Correspondent
Sellstrom Mfg. Co.
Sellstrom Industrial Park
One Sellstrom Dr.
Palatine,  IL  60067
Correspondent Contact LORI BUTLER
Regulation Number886.4750
Classification Product Code
HOY  
Date Received03/12/1993
Decision Date 11/12/1993
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
-
-