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FDA 510(k) Application Details - K093845
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K093845
Device Name
Staple, Implantable
Applicant
ETHICON, INC.
ROUTE 22 WEST
SOMERVILLE, NJ 08876-0151 US
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Contact
JOSEPH KICEINA
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Regulation Number
878.4750
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Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
12/15/2009
Decision Date
04/07/2010
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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