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FDA 510(k) Application Details - K110663
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K110663
Device Name
Mesh, Surgical, Polymeric
Applicant
SOFRADIM PRODUCTION
15 CROSBY DRIVE
BEDFORD, MA 01730 US
Other 510(k) Applications for this Company
Contact
JAMES MCMAHON
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
03/08/2011
Decision Date
08/11/2011
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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