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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 K880489
Device Name CLEAR EYE GARTER SHIELD
Applicant
EYE GARTER COMPANY, INC.
8535 WEST BELLFORT
HOUSTON,  TX  77071
Applicant Contact GOFFMAN, MD
Correspondent
EYE GARTER COMPANY, INC.
8535 WEST BELLFORT
HOUSTON,  TX  77071
Correspondent Contact GOFFMAN, MD
Regulation Number886.4750
Classification Product Code
HOY  
Date Received02/04/1988
Decision Date 08/08/1988
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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