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FDA 510(k) Application Details - K160654
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K160654
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
Covidien LLC
60 MIDDLETOWN AVE
North Haven, CT 06473 US
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Contact
Rebecca Magnanimo
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/08/2016
Decision Date
05/04/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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