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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 SOUTH MERIDIAN STREET
INDIANAPOLIS,  IN  46204
Applicant Contact STEVEN R LAMMERT
Correspondent
EYE PRO MEDICAL PRODUCTS, INC.
C/O BARNES & THORNBURG
11 SOUTH MERIDIAN STREET
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
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