510(k) K880815
K880815 is an FDA 510(k) premarket notification submitted by Niic U.S.A., Inc. for the device "DX101-T ULTRASONIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on April 13, 1988. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Niic U.S.A., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 1988
- Date Received
- February 17, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type