| Device Classification Name |
Filter, Bacterial, Breathing-Circuit
|
| 510(k) Number |
K930760 |
| Device Name |
MED-PLASTICS INTL., INC. BREATHING FILTER |
| Applicant |
| Med-Plastics Intl., Inc. |
| 5668 W. 73rd. St. |
|
Indianapolis,
IN
46278
|
|
| Applicant Contact |
MICHAEL CAMPBELL |
| Correspondent |
| Med-Plastics Intl., Inc. |
| 5668 W. 73rd. St. |
|
Indianapolis,
IN
46278
|
|
| Correspondent Contact |
MICHAEL CAMPBELL |
| Regulation Number | 868.5260 |
| Classification Product Code |
|
| Date Received | 02/12/1993 |
| Decision Date | 03/11/1993 |
| 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
|
|
|