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FDA 510(k) Application Details - K163098
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K163098
Device Name
Staple, Implantable
Applicant
Covidien LLC
60 MIDDLETOWN AVENUE
NORTH HAVEN, CT 06473 US
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Contact
REBECCA BREWER
Other 510(k) Applications for this Contact
Regulation Number
878.4750
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Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
11/07/2016
Decision Date
12/05/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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