The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa System 200c,t & M Ultrasonic Surgical Aspira..
Device ID | K884412 |
510k Number | K884412 |
Device Name: | CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA. |
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 |