| 510(k) Number |
K863627 |
| Device Name |
MICRO SURGICAL DRILL SYSTEM |
| Applicant |
| Acumed Instruments Corp. |
| 345 Puente Dr. |
|
Santa Barbara,
CA
93110
|
|
| Applicant Contact |
DAVE ESSLINGER |
| Correspondent |
| Acumed Instruments Corp. |
| 345 Puente Dr. |
|
Santa Barbara,
CA
93110
|
|
| Correspondent Contact |
DAVE ESSLINGER |
| Date Received | 09/17/1986 |
| Decision Date | 10/02/1986 |
| 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
|