| Device Classification Name |
Needle, Conduction, Anesthetic (W/Wo Introducer)
|
| 510(k) Number |
K894882 |
| Device Name |
INFILTRATION PUMP SYRINGE |
| Applicant |
| R. J. Doyle, Inc. |
| P.O. Box 278 |
|
Spirit Lake,
ID
83869
|
|
| Applicant Contact |
N HAMACHER,MD |
| Correspondent |
| R. J. Doyle, Inc. |
| P.O. Box 278 |
|
Spirit Lake,
ID
83869
|
|
| Correspondent Contact |
N HAMACHER,MD |
| Regulation Number | 868.5150 |
| Classification Product Code |
|
| Date Received | 08/01/1989 |
| Decision Date | 11/30/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
Anesthesiology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|