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510(k) K162752

ARTIA Reconstructive Tissue Matrix Perforated by Lifecell Corporation — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2017
Date Received
September 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

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  • K142326 — HP Tissue Matrix (December 23, 2014)

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