| Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
| 510(k) Number |
K771819 |
| Device Name |
CABG RINGS |
| Applicant |
| A&A Ent. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Correspondent |
| A&A Ent. |
| 803 N. Front St. Suite 3 |
|
Mchenry,
IL
60050
|
|
| Regulation Number | 870.3450 |
| Classification Product Code |
|
| Date Received | 09/26/1977 |
| Decision Date | 10/21/1977 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|