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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K142436
Device Name 3S Safety Insulin Syringe
Applicant
Sincere Medical Device Co., Ltd.
Rm.218, 2f., #183, Zhouzi St.
Taipei City,  TW 114
Applicant Contact Garfield Wang
Correspondent
Sincere Medical Device Co., Ltd.
Rm.218, 2f., #183, Zhouzi St.
Taipei City,  TW 114
Correspondent Contact Garfield Wang
Regulation Number880.5860
Classification Product Code
MEG  
Date Received08/29/2014
Decision Date 02/19/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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