The following data is part of a premarket notification filed by Valleylab, Inc. with the FDA for Cusa Excel Ultrasonic Surgical Aspirator System.
| Device ID | K981262 |
| 510k Number | K981262 |
| Device Name: | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 Boulder, CO 80301 |
| Contact | Julie Ross |
| Correspondent | Julie Ross VALLEYLAB, INC. 5920 LONGBOW DR. P.O. BOX 9015 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 | 1998-04-07 |
| Decision Date | 1998-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M273CUSAEXCEL1 | K981262 | 000 |