| 510(k) Number |
K840641 |
| Device Name |
VESSEL DILATOR |
| Applicant |
| Aries Medical, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| Aries Medical, Inc. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Date Received | 02/14/1984 |
| Decision Date | 02/14/1984 |
| Decision |
SE - Postmarket Surveillance Required
(SESP) |
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|