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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 K963083
Device Name LINEA MILANO SUNGLASSES, KALEIDO SUNGLASSES PLASTIC AND METAL FRAMES
Applicant
Piazza Optical Corp.
12955 Biscayne Blvd., #314
North Miami,  FL  33181
Applicant Contact SILVANO SAKAL
Correspondent
Piazza Optical Corp.
12955 Biscayne Blvd., #314
North Miami,  FL  33181
Correspondent Contact SILVANO SAKAL
Regulation Number886.5850
Classification Product Code
HQY  
Date Received08/08/1996
Decision Date 08/26/1996
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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