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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sunglasses (Non-Prescription Including Photosensitive)
510(k) Number K922120
Device Name SERIOUS SKINGLASSES
Applicant
Serious Skinglasses
275 Winwood Ave.
Pacifica,  CA  94044
Correspondent
Serious Skinglasses
275 Winwood Ave.
Pacifica,  CA  94044
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/05/1992
Decision Date 06/21/1993
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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