FDA 510(k) Application Details - K142359

Device Classification Name Clamp, Vascular

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510(K) Number K142359
Device Name Clamp, Vascular
Applicant Lepu Medical Technology (Beijing) Co., LTD
No. 37 Chaoqian Road
Beijing 102200 CN
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Contact Kim Xiangdan
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 08/25/2014
Decision Date 10/23/2014
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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