| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K860086 |
| Device Name |
ENTERAL NUTRITION PUMPS PN 1000 AND VM 05 |
| Applicant |
| Vial Medical , Ltd. |
| 4515 Boul. Poirier |
| Ville St-Laurent (Quebec) |
|
H4r 2a4 Canada,
CA
|
|
| Applicant Contact |
BERNARD VILLATTE |
| Correspondent |
| Vial Medical , Ltd. |
| 4515 Boul. Poirier |
| Ville St-Laurent (Quebec) |
|
H4r 2a4 Canada,
CA
|
|
| Correspondent Contact |
BERNARD VILLATTE |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 01/09/1986 |
| Decision Date | 03/24/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|