The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa System 200c Ultrasonic Aspirator/cusa System 200t Ultrasonic Aspirator/cusa Lap Accessory.
Device ID | K964601 |
510k Number | K964601 |
Device Name: | CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY |
Classification | Instrument, Ultrasonic Surgical |
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 | LFL |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-18 |
Decision Date | 1997-01-16 |
Summary: | summary |