| 510(k) Number |
K864637 |
| Device Name |
MODIFIED ESCHMANN DILATATION CATHETER |
| Applicant |
| Eschmann Bros. & Walsh , Ltd. |
| Peter Rd., Lancing |
|
Sussex Bn15 8tj,
GB
|
|
| Applicant Contact |
CLEVETT |
| Correspondent |
| Eschmann Bros. & Walsh , Ltd. |
| Peter Rd., Lancing |
|
Sussex Bn15 8tj,
GB
|
|
| Correspondent Contact |
CLEVETT |
| Date Received | 11/19/1986 |
| Decision Date | 01/06/1987 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|