The following data is part of a premarket notification filed by Mutoh America Co., Ltd. with the FDA for Sonopet Model Ust-2001 Ultrasonic Surgical Aspirator.
| Device ID | K010309 |
| 510k Number | K010309 |
| Device Name: | SONOPET MODEL UST-2001 ULTRASONIC SURGICAL ASPIRATOR |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | MUTOH AMERICA CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel] Kamm |
| Correspondent | Daniel] Kamm MUTOH AMERICA CO., LTD. PO BOX 7007 Deerfield, IL 60015 |
| 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 | 2001-02-01 |
| Decision Date | 2001-04-18 |