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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 K880666
Device Name ULTRAVIOLET LIGHT PROTECTVE EYEWERE
Applicant
Free Sun Intl. AB
6401 Wilbur Ave.
Reseda,  CA  91335
Applicant Contact MILO J SMITH
Correspondent
Free Sun Intl. AB
6401 Wilbur Ave.
Reseda,  CA  91335
Correspondent Contact MILO J SMITH
Regulation Number886.4750
Classification Product Code
HOY  
Date Received02/18/1988
Decision Date 06/28/1988
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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