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FDA 510(k) Application Details - K080253
Device Classification Name
Tube, Gastro-Enterostomy
More FDA Info for this Device
510(K) Number
K080253
Device Name
Tube, Gastro-Enterostomy
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL, GA 30076 US
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Contact
SHERRY SAURINI
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KGC
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More FDA Info for this Product Code
Date Received
01/31/2008
Decision Date
02/26/2008
Decision
SESK - SUBST EQUIV - KIT
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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