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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 K953920
Device Name REVERT SUNGLASSES & POLAR SUNGLASSES
Applicant
Bella Occhiali, Inc.
2174 Hewlett Ave., #100
Merrick,  NY  11566
Applicant Contact MICHAEL J DE CICCO
Correspondent
Bella Occhiali, Inc.
2174 Hewlett Ave., #100
Merrick,  NY  11566
Correspondent Contact MICHAEL J DE CICCO
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/21/1995
Decision Date 09/12/1995
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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