The following data is part of a premarket notification filed by Niic U.s.a., Inc. with the FDA for Dx101 Ultrasonic Surgical System.
| Device ID | K880814 |
| 510k Number | K880814 |
| Device Name: | DX101 ULTRASONIC SURGICAL SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | NIIC U.S.A., INC. 460 SEAPORT CT., SUITE 101 Redwood City, CA 94063 |
| Contact | Noby H Masuo |
| Correspondent | Noby H Masuo NIIC U.S.A., INC. 460 SEAPORT CT., SUITE 101 Redwood City, CA 94063 |
| 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 | 1988-02-17 |
| Decision Date | 1988-04-13 |