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510(k) K162193

Device
XenMatrix AB Surgical Graft
Applicant
C.R. Bard
510(k) number
K162193
Product code
PIJ  
Decision
Substantially Equivalent (SESE)
Decision date
2016-12-23
Date received
2016-08-04
Regulation
878.3300
Classification name
Collagen Surgical Mesh Containing Drugs
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tony John
Address
100 Crossings Blvd. Warwick RI US 02886 02886

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PIJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151177XenMatrix AB Surgical GraftC. R. Bard2015-07-30
K133223XENMATRIX AB SURGICAL GRAFTC.R. Bard, Inc.2014-09-19

Legacy Summary#

summary

FDA Review#

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