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FDA 510(k) Application Details - K113600
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K113600
Device Name
Clamp, Vascular
Applicant
SYNEXMED (SHENZHEN) COMPANY LIMITED
B-11/F,ZTY Buliding,TaoHuaRd,
Futian Free Trade Zone,ShenZhe
SHENZHEN, GUANGDONG 518038 CN
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ERIC CHIEN
Other 510(k) Applications for this Contact
Regulation Number
870.4450
More FDA Info for this Regulation Number
Classification Product Code
DXC
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More FDA Info for this Product Code
Date Received
12/05/2011
Decision Date
02/08/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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