FDA 510(k) Application Details - K001916

Device Classification Name Tubes, Gastrointestinal (And Accessories)

  More FDA Info for this Device
510(K) Number K001916
Device Name Tubes, Gastrointestinal (And Accessories)
Applicant NOVARTIS NUTRITION CORP.
5320 WEST 23RD ST.
PO BOX 370
MINNEAPOLIS, MN 55440 US
Other 510(k) Applications for this Company
Contact SHARON MARTIN
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 06/23/2000
Decision Date 02/16/2001
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