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FDA 510(k) Application Details - K100365
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K100365
Device Name
Tubes, Gastrointestinal (And Accessories)
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
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/2010
Decision Date
05/20/2010
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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