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FDA 510(k) Application Details - K121289
Device Classification Name
More FDA Info for this Device
510(K) Number
K121289
Device Name
LTM-LABAROSCOPIC SURGICAL MESH
Applicant
LIFECELL CORP.
ONE MILLENNIUM WAY
BRANCHBURG, NJ 08876 US
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Contact
MARK R JAKUBOWSKI
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/30/2012
Decision Date
08/03/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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