K032690 is an FDA 510(k) clearance for the MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Misonix, Inc. (Farmingdale, US). The FDA issued a Cleared decision on December 9, 2003, 98 days after receiving the submission on September 2, 2003.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K032690 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 2003 |
| Decision Date | December 09, 2003 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |