| Device Classification Name |
Instruments, Surgical, Cardiovascular
|
| 510(k) Number |
K882479 |
| Device Name |
26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP |
| Applicant |
| Medtronic Blood Systems, Inc. |
| 4633 E. Lapalma Ave. |
|
Anaheim,
CA
92807
|
|
| Applicant Contact |
DENNIE E DYER |
| Correspondent |
| Medtronic Blood Systems, Inc. |
| 4633 E. Lapalma Ave. |
|
Anaheim,
CA
92807
|
|
| Correspondent Contact |
DENNIE E DYER |
| Regulation Number | 870.4500 |
| Classification Product Code |
|
| Date Received | 06/16/1988 |
| Decision Date | 07/18/1988 |
| 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
|
|
|