| Device Classification Name |
Syringe, Piston
|
| 510(k) Number |
K880894 |
| Device Name |
ALLERGIST SYRINGES |
| Applicant |
| Abco Dealers, Inc. |
| 6601 W. Mill Rd. |
| P.O. Box 23090 |
|
Milwaukee,
WI
53218 -1238
|
|
| Applicant Contact |
MOLLY PETR |
| Correspondent |
| Abco Dealers, Inc. |
| 6601 W. Mill Rd. |
| P.O. Box 23090 |
|
Milwaukee,
WI
53218 -1238
|
|
| Correspondent Contact |
MOLLY PETR |
| Regulation Number | 880.5860 |
| Classification Product Code |
|
| Date Received | 03/02/1988 |
| Decision Date | 03/31/1988 |
| 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
|
|
|