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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 K941060
Device Name ALPINA EYEWEAR
Applicant
Alpina High Tech Sports Eyewear
3320 NW, 53rd St.
Suite 202
Ft. Lauderdale,  FL  33309
Applicant Contact JAMES J ARAIZI
Correspondent
Alpina High Tech Sports Eyewear
3320 NW, 53rd St.
Suite 202
Ft. Lauderdale,  FL  33309
Correspondent Contact JAMES J ARAIZI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/08/1994
Decision Date 05/17/1994
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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