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FDA 510(k) Application Details - K102291
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K102291
Device Name
Staple, Implantable
Applicant
COVIDIEN
60 MIDDLETOWN DR
NORTH HAVEN, CT 06473 US
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Contact
TIM M LOHNES
Other 510(k) Applications for this Contact
Regulation Number
878.4750
More FDA Info for this Regulation Number
Classification Product Code
GDW
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More FDA Info for this Product Code
Date Received
08/12/2010
Decision Date
09/15/2010
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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