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FDA 510(k) Application Details - K142359
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K142359
Device Name
Clamp, Vascular
Applicant
Lepu Medical Technology (Beijing) Co., LTD
No. 37 Chaoqian Road
Beijing 102200 CN
Other 510(k) Applications for this Company
Contact
Kim Xiangdan
Other 510(k) Applications for this Contact
Regulation Number
870.4450
More FDA Info for this Regulation Number
Classification Product Code
DXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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