The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa(r) Syst 200ct/200t Ultra Aspir Lap/cem Access.
Device ID | K934628 |
510k Number | K934628 |
Device Name: | CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS |
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 | 1993-09-15 |
Decision Date | 1995-07-11 |