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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 K965170
Device Name ROCCOBAROCCO & PRO-DYNAMIX
Applicant
Michelangelo, Inc.
2901 Commerce Park Dr.
Boynton Beach,  FL  33426
Applicant Contact FIDENZIO BIZZOTTO
Correspondent
Michelangelo, Inc.
2901 Commerce Park Dr.
Boynton Beach,  FL  33426
Correspondent Contact FIDENZIO BIZZOTTO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received12/24/1996
Decision Date 03/11/1997
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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