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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 K912608
Device Name STAR*SHADES(TM) SUNGLASSES
Applicant
Nalpac , Ltd.
8700 Capital
Oak Park,  MI  48237
Applicant Contact RALPH CAPLAN
Correspondent
Nalpac , Ltd.
8700 Capital
Oak Park,  MI  48237
Correspondent Contact RALPH CAPLAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/12/1991
Decision Date 08/21/1991
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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