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FDA 510(k) Application Details - K103445
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K103445
Device Name
Mesh, Surgical, Polymeric
Applicant
ALACER BIOMEDICAL INC
200 BOSTON AVENUE
SUITE 3700
MEDFORD, MA 02155 US
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Contact
CONNIE GARRISON
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
FTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/24/2010
Decision Date
02/22/2011
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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