The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa System 200h Ultrasonic Surgical Aspirator.
| Device ID | K884413 |
| 510k Number | K884413 |
| Device Name: | CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR |
| Classification | Device, Neurosurgical Fragmentation And Aspiration |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Contact | Peggy Walline |
| Correspondent | Peggy Walline VALLEYLAB, INC. 5920 LONGBOW DR. Boulder, CO 80301 |
| Product Code | LBK |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-20 |
| Decision Date | 1988-12-02 |