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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K935919
Device Name SUNGLASSES
Applicant
Ja-Ru, Inc.
4030 Phillips Highway
Jacksonville,  FL  32207 -6835
Applicant Contact JACK SELEVAN
Correspondent
Ja-Ru, Inc.
4030 Phillips Highway
Jacksonville,  FL  32207 -6835
Correspondent Contact JACK SELEVAN
Regulation Number886.5844
Classification Product Code
HQG  
Date Received12/08/1993
Decision Date 02/16/1994
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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