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FDA 510(k) Application Details - K102325
Device Classification Name
Staple, Implantable
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510(K) Number
K102325
Device Name
Staple, Implantable
Applicant
COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA
60 Middletown Ave
North Haven, CT 06473 US
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Contact
NISHITH DESAI
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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
08/17/2010
Decision Date
10/13/2010
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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