| Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
| 510(k) Number |
K935633 |
| Device Name |
NO-MES |
| Applicant |
| Ethox Corp. |
| 251 Seneca St. |
|
Buffalo,
NY
14204
|
|
| Applicant Contact |
JOHN A YOUNG |
| Correspondent |
| Ethox Corp. |
| 251 Seneca St. |
|
Buffalo,
NY
14204
|
|
| Correspondent Contact |
JOHN A YOUNG |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 11/23/1993 |
| Decision Date | 09/30/1994 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|