Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K043258
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K043258
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
TELEFLEX MEDICAL
50 PLANTATION DRIVE
TALL PINES PARK
JAFFERY, NH 03452 US
Other 510(k) Applications for this Company
Contact
SUSAN KAGAN
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
11/24/2004
Decision Date
12/16/2004
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact