510(k) K162752

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

K162752 is an FDA 510(k) premarket notification submitted by Lifecell Corporation for the device "ARTIA Reconstructive Tissue Matrix Perforated". The FDA issued a decision of Substantially Equivalent on February 24, 2017. The device falls under product code FTM (Mesh, Surgical), a Class II device regulated under 21 CFR 878.3300. Lifecell Corporation has at least 4 other 510(k) clearances on record.

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