K934628 is an FDA 510(k) clearance for the CUSA(R) SYST 200CT/200T ULTRA ASPIR LAP/CEM ACCESS, a Instrument, Ultrasonic Surgical, submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on July 11, 1995, 664 days after receiving the submission on September 15, 1993. This device falls under the General & Plastic Surgery review panel.
| 510(k) Number | K934628 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 15, 1993 |
| Decision Date | July 11, 1995 |
| Days to Decision | 664 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |