| Device Classification Name |
Instrument, Ultrasonic Surgical
|
| 510(k) Number |
K942095 |
| Device Name |
SONOCA III |
| Applicant |
| Holl Meditronics, Inc. |
| 4 Marconi Ct. |
|
Bolton, Ontario,
CA
L7E 1E7
|
|
| Applicant Contact |
BILL H HOLL |
| Correspondent |
| Holl Meditronics, Inc. |
| 4 Marconi Ct. |
|
Bolton, Ontario,
CA
L7E 1E7
|
|
| Correspondent Contact |
BILL H HOLL |
| Classification Product Code |
|
| Date Received | 04/20/1994 |
| Decision Date | 11/09/1994 |
| 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
|
|
|