| Device Classification Name |
Filter, Bacterial, Breathing-Circuit
|
| 510(k) Number |
K923661 |
| Device Name |
QUADRASORB FILTER |
| Applicant |
| Union Broach, Div. Moyco Industries, Inc. |
| P.O. Box 508 |
| Aberdeen Rd. |
|
Emigsville,
PA
17318
|
|
| Applicant Contact |
LONNIE M GRAYBILL |
| Correspondent |
| Union Broach, Div. Moyco Industries, Inc. |
| P.O. Box 508 |
| Aberdeen Rd. |
|
Emigsville,
PA
17318
|
|
| Correspondent Contact |
LONNIE M GRAYBILL |
| Regulation Number | 868.5260 |
| Classification Product Code |
|
| Date Received | 07/22/1992 |
| Decision Date | 10/20/1992 |
| 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
|
|
|