ACELL UBM SURGICAL MESH

Mesh, Surgical

ACELL, INC

The following data is part of a premarket notification filed by Acell, Inc with the FDA for Acell Ubm Surgical Mesh.

Pre-market Notification Details

Device IDK040621
510k NumberK040621
Device Name:ACELL UBM SURGICAL MESH
ClassificationMesh, Surgical
Applicant ACELL, INC 5610 WISCONSIN AVE #304 Chevy Chase,  MD  20815
ContactPatsy J Trisler
CorrespondentPatsy J Trisler
ACELL, INC 5610 WISCONSIN AVE #304 Chevy Chase,  MD  20815
Product CodeFTM  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-09
Decision Date2004-04-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00386190001769 K040621 000
00386190001752 K040621 000
00386190001745 K040621 000
00386190001738 K040621 000

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