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FDA 510(k) Application Details - K093402
Device Classification Name
Staple, Implantable
More FDA Info for this Device
510(K) Number
K093402
Device Name
Staple, Implantable
Applicant
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO
60 MIDDLETOWN AVENUE
NORTH HAVEN, CT 06473 US
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Contact
REBECCA RONNER
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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
11/02/2009
Decision Date
11/12/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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