K990572 is an FDA 510(k) clearance for the SONOTOME. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Sonokinetics, Inc. (Hopkinton, US). The FDA issued a Cleared decision on May 21, 1999, 87 days after receiving the submission on February 23, 1999.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K990572 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1999 |
| Decision Date | May 21, 1999 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |