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FDA 510(k) Application Details - K170348
Device Classification Name
Staple, Implantable
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510(K) Number
K170348
Device Name
Staple, Implantable
Applicant
Covidien
60 Middletown Avenue
North Haven, CT 06473 US
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Contact
Katherine Y. Choi
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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
02/03/2017
Decision Date
03/02/2017
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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