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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 K952890
Device Name SUNGLASSES
Applicant
Isohyper
15 W. 37 St.
New York,  NY  10018
Applicant Contact ELLIOT MIZRAHI
Correspondent
Isohyper
15 W. 37 St.
New York,  NY  10018
Correspondent Contact ELLIOT MIZRAHI
Regulation Number886.5850
Classification Product Code
HQY  
Date Received06/23/1995
Decision Date 07/12/1995
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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