| Device Classification Name |
Filter, Bacterial, Breathing-Circuit
|
| 510(k) Number |
K833269 |
| Device Name |
RESPIR GARD BACTERIA FILTER |
| Applicant |
| Marquest Medical Products, Inc. |
| 112 Inverness Cir., |
| Suite A |
|
Englewood,
CO
80112
|
|
| Applicant Contact |
Robert J McKinnon |
| Correspondent |
| Marquest Medical Products, Inc. |
| 112 Inverness Cir., |
| Suite A |
|
Englewood,
CO
80112
|
|
| Correspondent Contact |
Robert J McKinnon |
| Regulation Number | 868.5260 |
| Classification Product Code |
|
| Date Received | 09/21/1983 |
| Decision Date | 10/31/1983 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Anesthesiology
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|