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FDA 510(k) Application Details - K162193
Device Classification Name
More FDA Info for this Device
510(K) Number
K162193
Device Name
XenMatrix AB Surgical Graft
Applicant
C.R. Bard
100 Crossings Boulevard
Warwick, RI 02886 US
Other 510(k) Applications for this Company
Contact
Tony John
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PIJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/04/2016
Decision Date
12/23/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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