K964601 is an FDA 510(k) clearance for the CUSA SYSTEM 200C ULTRASONIC ASPIRATOR/CUSA SYSTEM 200T ULTRASONIC ASPIRATOR/CUSA LAP ACCESSORY, a Instrument, Ultrasonic Surgical, submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on January 16, 1997, 59 days after receiving the submission on November 18, 1996. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K964601 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 1996 |
| Decision Date | January 16, 1997 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |