| Device Classification Name |
Instrument, Ultrasonic Surgical
|
| 510(k) Number |
K893926 |
| Device Name |
SONOCA ULTRASONIC SURGICAL SYSTEM |
| Applicant |
| Holl Meditronics, Inc. |
| P.O. Box 396 |
|
Bolton, Ontario,
CA
L7E 5T3
|
|
| Applicant Contact |
WILLIAM H HOLL |
| Correspondent |
| Holl Meditronics, Inc. |
| P.O. Box 396 |
|
Bolton, Ontario,
CA
L7E 5T3
|
|
| Correspondent Contact |
WILLIAM H HOLL |
| Classification Product Code |
|
| Date Received | 05/31/1989 |
| Decision Date | 11/14/1989 |
| 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
|
|
|