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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 K942119
Device Name U-TOP ENTERPRISE CO SPECTACLE FRAMES & SUNGLASSES
Applicant
U-Top Enterprise Co., Ltd.
# 22 Chien Chen Rd., E.Dist
Taichung,  TW
Applicant Contact LINUS LIN
Correspondent
U-Top Enterprise Co., Ltd.
# 22 Chien Chen Rd., E.Dist
Taichung,  TW
Correspondent Contact LINUS LIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received05/03/1994
Decision Date 07/15/1994
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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