| Device Classification Name |
Marker, Ostia, Aorto-Saphenous Vein
|
| 510(k) Number |
K895369 |
| Device Name |
VOSS GRAFT MARKER |
| Applicant |
| Voss Medical Products |
| 4227 Centergate |
|
San Antonio,
TX
78217
|
|
| Applicant Contact |
STEVE HOLLOWAY |
| Correspondent |
| Voss Medical Products |
| 4227 Centergate |
|
San Antonio,
TX
78217
|
|
| Correspondent Contact |
STEVE HOLLOWAY |
| Classification Product Code |
|
| Date Received | 08/29/1989 |
| Decision Date | 09/27/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|