| Device Classification Name |
Arterial Blood Sampling Kit
|
| 510(k) Number |
K820875 |
| Device Name |
AUTOSTIK |
| Applicant |
| Marquest Medical Products, Inc. |
| 112 Inverness Circle, |
| Suite A |
|
Englewood,
CO
80112
|
|
| Applicant Contact |
Robert J McKinnon |
| Correspondent |
| Marquest Medical Products, Inc. |
| 112 Inverness Circle, |
| Suite A |
|
Englewood,
CO
80112
|
|
| Correspondent Contact |
Robertj J McKinnon |
| Regulation Number | 868.1100 |
| Classification Product Code |
|
| Date Received | 03/29/1982 |
| Decision Date | 05/07/1982 |
| 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
|
|
|