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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 K951439
Device Name SUNGLASSES
Applicant
Long Train Enterprise Co., Ltd.
# 257 Ming Chu Rd.
Taichung,  TW
Applicant Contact RICHARD LKIN
Correspondent
Long Train Enterprise Co., Ltd.
# 257 Ming Chu Rd.
Taichung,  TW
Correspondent Contact RICHARD LKIN
Regulation Number886.5850
Classification Product Code
HQY  
Date Received03/27/1995
Decision Date 04/18/1995
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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