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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 K925539
Device Name SUNGLASSES
Applicant
Sunshine Opticians, Inc.
P.O. Box 765
Tainan, Taiwan R.O.C.,  CN
Applicant Contact SHIEH
Correspondent
Sunshine Opticians, Inc.
P.O. Box 765
Tainan, Taiwan R.O.C.,  CN
Correspondent Contact SHIEH
Regulation Number886.5850
Classification Product Code
HQY  
Date Received11/02/1992
Decision Date 12/08/1993
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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