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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K152906
Device Name Disposable High Pressure Injector Syringe
Applicant
Wuxi Yushou Medical Appliances Co., Ltd.
# 215 Xigang Rd., Dongbeitang
Wuxi,  CN 214191
Applicant Contact Wu Feng
Correspondent
P&L Scientific
1430 S Dixie Hwy. Suite 105
Coral Gables,  FL  33146
Correspondent Contact Jun Peng
Regulation Number870.1650
Classification Product Code
DXT  
Date Received10/01/2015
Decision Date 11/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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