| Device Classification Name |
Filter, Bacterial, Breathing-Circuit
|
| 510(k) Number |
K880958 |
| Device Name |
LIFEGUARD BACTERIAL AND VIRAL FILTER |
| Applicant |
| Lifeguard Medical Products, Inc. |
| 7476 Shadeland Station Way |
|
Indianapolis,
IN
46256
|
|
| Applicant Contact |
CRAIG TRIMBLE |
| Correspondent |
| Lifeguard Medical Products, Inc. |
| 7476 Shadeland Station Way |
|
Indianapolis,
IN
46256
|
|
| Correspondent Contact |
CRAIG TRIMBLE |
| Regulation Number | 868.5260 |
| Classification Product Code |
|
| Date Received | 03/07/1988 |
| Decision Date | 04/27/1988 |
| 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
|
|
|