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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 K953629
Device Name SPECTACLE SUNGLASSES(NON-PRESCRIPTION)
Applicant
Lowinger Holdings, Inc.
19101 Mystic Pt.e Dr., #2407
Aventura,  FL  33180
Applicant Contact LEONARD LOWINGER
Correspondent
Lowinger Holdings, Inc.
19101 Mystic Pt.e Dr., #2407
Aventura,  FL  33180
Correspondent Contact LEONARD LOWINGER
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/24/1995
Decision Date 08/23/1995
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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