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
|
|
Correspondent Contact |
THOMAS A DOLD |
Regulation Number | 876.5980
|
Classification Product Code |
|
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
|
|
|