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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 K920764
Device Name SUNGLASSES AND EYEGLASS FRAMES
Applicant
New Optic Srl
605 Third Ave.
New York,  NY  10158
Applicant Contact PHILIPPE RADLEY
Correspondent
New Optic Srl
605 Third Ave.
New York,  NY  10158
Correspondent Contact PHILIPPE RADLEY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received02/19/1992
Decision Date 06/25/1992
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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