| 510(k) Number |
K860763 |
| Device Name |
RADTECH VASCULAR STENT |
| Applicant |
| Radtech, Inc. |
| 2610 San Mateo, NE Suite D |
|
Albuquerque,
NM
87110
|
|
| Applicant Contact |
JOHN W SOMERS |
| Correspondent |
| Radtech, Inc. |
| 2610 San Mateo, NE Suite D |
|
Albuquerque,
NM
87110
|
|
| Correspondent Contact |
JOHN W SOMERS |
| Date Received | 03/03/1986 |
| Decision Date | 03/28/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|