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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 K931408
Device Name SUNGLASSES
Applicant
Sunnycraft Philippines, Inc.
8th Floor , Quad Alpha Centrum
Bldg., 125 Pioneer St.
Mandaluyong City,  PH
Applicant Contact EDWARD TANG
Correspondent
Sunnycraft Philippines, Inc.
8th Floor , Quad Alpha Centrum
Bldg., 125 Pioneer St.
Mandaluyong City,  PH
Correspondent Contact EDWARD TANG
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/19/1993
Decision Date 10/01/1993
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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