| Device Classification Name |
Filter, Infusion Line
|
| 510(k) Number |
K942625 |
| Device Name |
1.2 MICRON AIR ELIMINATING FILTER |
| Applicant |
| The Medi-Dose Group |
| 1671 Loretta Ave. |
|
Feasterville,
PA
19047
|
|
| Applicant Contact |
MILTON BRAVERMAN |
| Correspondent |
| The Medi-Dose Group |
| 1671 Loretta Ave. |
|
Feasterville,
PA
19047
|
|
| Correspondent Contact |
MILTON BRAVERMAN |
| Regulation Number | 880.5440 |
| Classification Product Code |
|
| Date Received | 06/02/1994 |
| Decision Date | 10/07/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|