510(k) K071191

NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT by Novartis Nutrition Corp. — Product Code FPD

K071191 is an FDA 510(k) premarket notification submitted by Novartis Nutrition Corp. for the device "NOVARTIS COMPAT SURGICAL GASTROSTOMY JEJUNOSTOMY FEEDING TUBE KIT". The FDA issued a decision of Substantially Equivalent on July 23, 2007. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Novartis Nutrition Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2007
Date Received
April 30, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Tube, Feeding
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type