| Device Classification Name |
Tubing, Pressure And Accessories
|
| 510(k) Number |
K943110 |
| Device Name |
GAS SAMPLING INTERFACES |
| Applicant |
| Coast Medical, Inc. |
| 1060-H N. Batavia |
|
Orange,
CA
92867
|
|
| Applicant Contact |
DOUGLAS R MONGEON |
| Correspondent |
| Coast Medical, Inc. |
| 1060-H N. Batavia |
|
Orange,
CA
92867
|
|
| Correspondent Contact |
DOUGLAS R MONGEON |
| Regulation Number | 868.5860 |
| Classification Product Code |
|
| Date Received | 06/29/1994 |
| Decision Date | 08/19/1994 |
| 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
|
|
|