The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa(r) System 200c/200t/200m/200h Ultra Aspirator.
Device ID | K910696 |
510k Number | K910696 |
Device Name: | CUSA(R) SYSTEM 200C/200T/200M/200H ULTRA ASPIRATOR |
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 | 1991-02-19 |
Decision Date | 1991-06-11 |