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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 K875107
Device Name HEALTH CARE EYE PROTECTION
Applicant
Surgikos, Inc.
P.O. Box 130
Arlington,  TX  76010
Applicant Contact WALTER J MCQUADE
Correspondent
Surgikos, Inc.
P.O. Box 130
Arlington,  TX  76010
Correspondent Contact WALTER J MCQUADE
Regulation Number886.4750
Classification Product Code
HOY  
Date Received12/14/1987
Decision Date 03/21/1988
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
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