Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K093312
Device Classification Name
Tube, Gastro-Enterostomy
More FDA Info for this Device
510(K) Number
K093312
Device Name
Tube, Gastro-Enterostomy
Applicant
KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL, GA 30076 US
Other 510(k) Applications for this Company
Contact
LESTER PADILLA
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KGC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/22/2009
Decision Date
12/08/2009
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
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact