XENMATRIX AB SURGICAL GRAFT

Collagen Surgical Mesh Containing Drugs

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Xenmatrix Ab Surgical Graft.

Pre-market Notification Details

Device IDK133223
510k NumberK133223
Device Name:XENMATRIX AB SURGICAL GRAFT
ClassificationCollagen Surgical Mesh Containing Drugs
Applicant C.R. BARD, INC. 100 CROSSINGS BLVD. Warwick,  RI  02886
ContactTony John
CorrespondentTony John
C.R. BARD, INC. 100 CROSSINGS BLVD. Warwick,  RI  02886
Product CodePIJ  
Subsequent Product CodeFTM
Subsequent Product CodeOXH
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2013-10-21
Decision Date2014-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00801741074301 K133223 000
00801741074189 K133223 000
00801741074196 K133223 000
00801741074202 K133223 000
00801741074219 K133223 000
00801741074226 K133223 000
00801741074233 K133223 000
00801741074240 K133223 000
00801741074257 K133223 000
00801741074264 K133223 000
00801741074271 K133223 000
00801741074288 K133223 000
00801741074295 K133223 000
00801741074172 K133223 000

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