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 K873662
Device Name WINK-EASE PERSONAL PROTECTIVE EYEWEAR
Applicant
Eye Pro Medical Products, Inc.
C/O Barnes & Thornburg
11 S. Meridian St.
Indianapolis,  IN  46204
Applicant Contact STEVEN R LAMMERT
Correspondent
Eye Pro Medical Products, Inc.
C/O Barnes & Thornburg
11 S. Meridian St.
Indianapolis,  IN  46204
Correspondent Contact STEVEN R LAMMERT
Regulation Number886.4750
Classification Product Code
HOY  
Date Received09/10/1987
Decision Date 10/02/1987
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
-
-