Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix

Mesh, Surgical

ACELL, INC

The following data is part of a premarket notification filed by Acell, Inc with the FDA for Matristem Surgery Matrix Rs, Psm, Psmx, Matristem Pelvic Floor Matrix.

Pre-market Notification Details

Device IDK141084
510k NumberK141084
Device Name:Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
ClassificationMesh, Surgical
Applicant ACELL, INC 6640 ELI WHITNEY DR SUITE 200 Columbia,  MD  21046
ContactSalman Elmi
CorrespondentSalman Elmi
ACELL, INC 6640 ELI WHITNEY DR SUITE 200 Columbia,  MD  21046
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-28
Decision Date2015-06-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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