The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa System 200c,t,m,h Ultrasonic Aspirator.
| Device ID | K894600 |
| 510k Number | K894600 |
| Device Name: | CUSA SYSTEM 200C,T,M,H ULTRASONIC ASPIRATOR |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Mark Wenzel |
| Correspondent | Mark Wenzel VALLEYLAB, INC. 5920 LONGBOW DR. 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 | 1989-07-20 |
| Decision Date | 1990-01-19 |