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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 K933718
Device Name MUGNIER JERIK SUNGLASSES
Applicant
Huntley Global Ent.
920 Pines Lake Dr. W.
Wayne,  NJ  07470
Applicant Contact RUSSELL G N HUNTLEY
Correspondent
Huntley Global Ent.
920 Pines Lake Dr. W.
Wayne,  NJ  07470
Correspondent Contact RUSSELL G N HUNTLEY
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/30/1993
Decision Date 10/18/1993
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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