The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cooper Laser Sonics Cusa Model 200.
| Device ID | K950945 |
| 510k Number | K950945 |
| Device Name: | COOPER LASER SONICS CUSA MODEL 200 |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Contact | Peggy Walline |
| Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-18 |
| Decision Date | 1995-04-10 |