ACELL UBM SURGICAL MESH ML AND MLPLUS

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 Ml And Mlplus.

Pre-market Notification Details

Device IDK041140
510k NumberK041140
Device Name:ACELL UBM SURGICAL MESH ML AND MLPLUS
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 Received2004-04-30
Decision Date2004-07-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00386190001813 K041140 000
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00386190000519 K041140 000
00386190000502 K041140 000
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00386190000465 K041140 000
00386190000908 K041140 000
00386190000915 K041140 000
00386190000922 K041140 000
00386190001790 K041140 000
00386190001585 K041140 000
00386190001578 K041140 000
00386190001561 K041140 000
00386190001554 K041140 000
00386190001547 K041140 000
00386190001530 K041140 000
00386190001523 K041140 000
00386190000458 K041140 000

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