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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K132557
Device Name EWNL SAFETY SYRINGE WITH NEEDLE
Applicant
Jiamei-Un Co., Ltd.
5f, # 79, Sec 1, Nankan Rd.
Luzhu Township
Taoyuan County 338,  TW
Applicant Contact YU-HONG CHEN
Correspondent
Jiamei-Un Co., Ltd.
5f, # 79, Sec 1, Nankan Rd.
Luzhu Township
Taoyuan County 338,  TW
Correspondent Contact YU-HONG CHEN
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
MEG  
Date Received08/14/2013
Decision Date 06/03/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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