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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 K931389
Device Name ITEM # 754 HOT FLIP SHADES
Applicant
Ja-Ru, Inc.
4030 Phillips Hwy.
Jacksonville,  FL  32207
Applicant Contact RUSSELL SELEVAN
Correspondent
Ja-Ru, Inc.
4030 Phillips Hwy.
Jacksonville,  FL  32207
Correspondent Contact RUSSELL SELEVAN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/18/1993
Decision Date 10/06/1993
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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