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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 K951008
Device Name POWER RANGERS SUNGLASSES
Applicant
Siegel,Mandell & Davidson,P.C.
1515 Broadway
43rd Floor
New York,  NY  10036
Applicant Contact DAVID A EISEN
Correspondent
Siegel,Mandell & Davidson,P.C.
1515 Broadway
43rd Floor
New York,  NY  10036
Correspondent Contact DAVID A EISEN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/06/1995
Decision Date 05/02/1995
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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