| Device Classification Name |
Instrument, Ultrasonic Surgical
|
| 510(k) Number |
K933239 |
| Device Name |
CV720-727-000, MICROTIP AND FLUE PAK |
| Applicant |
| Valleylab, Inc. |
| 5920 Longbow Dr. |
|
Boulder,
CO
80301
|
|
| Applicant Contact |
LYNNE LEONARD |
| Correspondent |
| Valleylab, Inc. |
| 5920 Longbow Dr. |
|
Boulder,
CO
80301
|
|
| Correspondent Contact |
LYNNE LEONARD |
| Classification Product Code |
|
| Date Received | 07/02/1993 |
| Decision Date | 10/12/1993 |
| 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
|
|
|