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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 K962636
Device Name SUNGLASSES, GAUDI SUN LINE
Applicant
Gaudi Spa
162 E. Broadway St.
Oviedo,  FL  32765
Applicant Contact CALVIN HOWELL
Correspondent
Gaudi Spa
162 E. Broadway St.
Oviedo,  FL  32765
Correspondent Contact CALVIN HOWELL
Regulation Number886.5850
Classification Product Code
HQY  
Date Received07/05/1996
Decision Date 07/25/1996
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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