| Device Classification Name |
Filter, Bacterial, Breathing-Circuit
|
| 510(k) Number |
K922492 |
| Device Name |
SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER |
| Applicant |
| Specialty Packaging Producs, Inc. |
| 19 Leigh Fisher |
|
El Paso,
TX
79906
|
|
| Applicant Contact |
EDWARD F VALDEZ |
| Correspondent |
| Specialty Packaging Producs, Inc. |
| 19 Leigh Fisher |
|
El Paso,
TX
79906
|
|
| Correspondent Contact |
EDWARD F VALDEZ |
| Regulation Number | 868.5260 |
| Classification Product Code |
|
| Date Received | 05/27/1992 |
| Decision Date | 08/24/1992 |
| 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
|
|
|