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FDA 510(k) Application Details - K083776
Device Classification Name
Tube, Feeding
More FDA Info for this Device
510(K) Number
K083776
Device Name
Tube, Feeding
Applicant
CORPAK MEDSYSTEMS
100 CHADDICK DR.
WHEELING, IL 60090 US
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Contact
STEPHANIE WASIELEWSKI
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
FPD
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More FDA Info for this Product Code
Date Received
12/19/2008
Decision Date
03/05/2009
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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