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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K113148
Device Name E-PASS
Applicant
Synexmed(Shenzhen)Company Limited
B-11/F,Z Z Y Build.,Taohua Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Applicant Contact TONY ZHANG
Correspondent
Synexmed(Shenzhen)Company Limited
B-11/F,Z Z Y Build.,Taohua Rd.
Futian Free Trade Zone
Shenzhen,  CN 518038
Correspondent Contact TONY ZHANG
Regulation Number870.4290
Classification Product Code
DTL  
Subsequent Product Code
DQX  
Date Received10/24/2011
Decision Date 02/28/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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