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FDA 510(k) Application Details - K141084
Device Classification Name
Mesh, Surgical
More FDA Info for this Device
510(K) Number
K141084
Device Name
Mesh, Surgical
Applicant
ACELL, INC
6640 ELI WHITNEY DR
SUITE 200
COLUMBIA, MD 21046 US
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Contact
Salman Elmi
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
FTM
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More FDA Info for this Product Code
Date Received
04/28/2014
Decision Date
06/17/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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