| Device Classification Name |
Infusor, Pressure, For I.V. Bags
|
| 510(k) Number |
K894927 |
| Device Name |
SURGI SQUEEZ |
| Applicant |
| Ethox Corp. |
| 251 Seneca St. |
|
Buffalo,
NY
14204
|
|
| Applicant Contact |
JOHN YOUNG |
| Correspondent |
| Ethox Corp. |
| 251 Seneca St. |
|
Buffalo,
NY
14204
|
|
| Correspondent Contact |
JOHN YOUNG |
| Regulation Number | 880.5420 |
| Classification Product Code |
|
| Date Received | 08/02/1989 |
| Decision Date | 09/11/1989 |
| 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
|
|
|