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FDA 510(k) Application Details - K202507
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K202507
Device Name
Staple, Implantable
Applicant
Covidien
Rooms 501, 502, 601, 602 No.3 building
No.2388, Chen Hang Road
Min Hang District, Shanghai 201114 CN
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Contact
Leo Chen
Other 510(k) Applications for this Contact
Regulation Number
878.4750
More FDA Info for this Regulation Number
Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
08/31/2020
Decision Date
01/21/2021
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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