COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K080340
Device Name COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG
Applicant
NOVARTIS NUTRITION CORP.
12500 whitewater drive
minnetonka, 
MN 
55343

Applicant Contact thomas a dold
Correspondent
NOVARTIS NUTRITION CORP.
12500 whitewater drive
minnetonka, 
MN 
55343

Correspodent Contact thomas a dold
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 02/08/2008
Decision Date 03/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No