| Device Classification Name |
Syringe, Piston
|
| 510(k) Number |
K884985 |
| Device Name |
MODIFIED 10CC SYRINGE CONTROL RING SET |
| Applicant |
| Procedure Products, Inc. |
| 1801 W. 4th Plain Blvd. |
|
Vancouver,
WA
98660
|
|
| Applicant Contact |
BOB EVERETT |
| Correspondent |
| Procedure Products, Inc. |
| 1801 W. 4th Plain Blvd. |
|
Vancouver,
WA
98660
|
|
| Correspondent Contact |
BOB EVERETT |
| Regulation Number | 880.5860 |
| Classification Product Code |
|
| Date Received | 12/01/1988 |
| Decision Date | 12/20/1988 |
| 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
|
|
|