FDA 510(k) Application Details - K111837

Device Classification Name Clamp, Vascular

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510(K) Number K111837
Device Name Clamp, Vascular
Applicant LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD
NO. 37 CHAOQIAN ROAD
BEIJING, CHANGPING DISTRICT 102200 CN
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Contact SHAN ZHAO
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 06/29/2011
Decision Date 09/27/2011
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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