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FDA 510(k) Application Details - K171619
Device Classification Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
More FDA Info for this Device
510(K) Number
K171619
Device Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Applicant
Cook Ireland Ltd
O'Halloran Road, National Technology Park
Limerick IE
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Contact
Laura Graham
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Regulation Number
876.5980
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Classification Product Code
FEG
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More FDA Info for this Product Code
Date Received
06/02/2017
Decision Date
08/01/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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