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FDA 510(k) Application Details - K083153
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K083153
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
HOLLISTER, INC.
2000 HOLLISTER DR.
LIBERTYVILLE, IL 60048 US
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Contact
CHRIS STUKEL
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
10/24/2008
Decision Date
02/04/2009
Decision
SESK - SUBST EQUIV - KIT
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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