FDA 510(k) Application Details - K113600

Device Classification Name Clamp, Vascular

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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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Contact ERIC CHIEN
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Regulation Number 870.4450

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Classification Product Code DXC
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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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