510(k) K991668

COMPAT JEJUNOSTOMY TUBE KIT, MODEL 088OXX (XX=16,14, OR 12) by Novartis Nutrition Corp. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1999
Date Received
May 14, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type