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FDA 510(k) Application Details - K123318
Device Classification Name
Staple, Implantable
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510(K) Number
K123318
Device Name
Staple, Implantable
Applicant
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 Middletown Ave
North Haven, CT 06473 US
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Contact
SARAH RIZK
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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
10/25/2012
Decision Date
12/18/2012
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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