Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K150711
Device Classification Name
More FDA Info for this Device
510(K) Number
K150711
Device Name
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
Applicant
COVIDIEN
15 HAMPSHIRE STREET
MANSFILED, MA 02048 US
Other 510(k) Applications for this Company
Contact
Jim Welsh
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/19/2015
Decision Date
10/08/2015
Decision
SESE - SUBST EQUIV
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact