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510(k) K133223

XENMATRIX AB SURGICAL GRAFT by C.R. Bard, Inc. — Product Code PIJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2014
Date Received
October 21, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collagen Surgical Mesh Containing Drugs
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

Reinforcement of soft tissue where weakness exists.

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Other clearances for product code PIJ

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