| Device Classification Name |
Pump, Infusion
|
| 510(k) Number |
K860502 |
| Device Name |
G.A.S./GRIESHABER AIR SYSTEM |
| Applicant |
| Grieshaber & Co. |
| 1056 Trenton Rd. |
| P.O. Box 807 |
|
Fallisington,
PA
19054
|
|
| Applicant Contact |
JOHN RICHMOND |
| Correspondent |
| Grieshaber & Co. |
| 1056 Trenton Rd. |
| P.O. Box 807 |
|
Fallisington,
PA
19054
|
|
| Correspondent Contact |
JOHN RICHMOND |
| Regulation Number | 880.5725 |
| Classification Product Code |
|
| Date Received | 02/11/1986 |
| Decision Date | 02/27/1986 |
| 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
|
|
|