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FDA 510(k) Application Details - K063648
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K063648
Device Name
Mesh, Surgical, Polymeric
Applicant
MAST BIOSURGERY USA INC.
6749 TOP GUN ST., SUITE C
SAN DIEGO, CA 92121 US
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Contact
KENNETH K KLEINHENZ
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
FTL
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More FDA Info for this Product Code
Date Received
12/07/2006
Decision Date
03/07/2007
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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