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FDA 510(k) Application Details - K053410
Device Classification Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
More FDA Info for this Device
510(K) Number
K053410
Device Name
Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Applicant
KENDALL
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact
JIM WELSH
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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
12/07/2005
Decision Date
01/06/2006
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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