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FDA 510(k) Application Details - K132314
Device Classification Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
More FDA Info for this Device
510(K) Number
K132314
Device Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Applicant
MEDLINE INDUSTRIES, INC.
ONE MEDLINE PLACE
MUNDELEIN, IL 60060 US
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Contact
MATT CLAUSEN
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
FEG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/25/2013
Decision Date
09/18/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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