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FDA 510(k) Application Details - K143129
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K143129
Device Name
Staple, Implantable
Applicant
EziSurg Medical Co.,Ltd.
Room 312, Bldg 2, No.1690 Cailun Road
Zhangjiang High-Tech Park,Pudong
Shanghai 201203 CN
Other 510(k) Applications for this Company
Contact
Johnny Yan
Other 510(k) Applications for this Contact
Regulation Number
878.4750
More FDA Info for this Regulation Number
Classification Product Code
GDW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2014
Decision Date
01/29/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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