| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K871806 |
| Device Name |
PROVIDER IV. MODEL 5000 INFUSION DEVICE |
| Applicant |
| Pancretec, Inc. |
| 15222-B Ave. Of Science |
|
San Diego,
CA
92128
|
|
| Applicant Contact |
ALAN R SEACORD |
| Correspondent |
| Pancretec, Inc. |
| 15222-B Ave. Of Science |
|
San Diego,
CA
92128
|
|
| Correspondent Contact |
ALAN R SEACORD |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 05/08/1987 |
| Decision Date | 10/22/1987 |
| 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
|
|
|