510(k) K003824
K003824 is an FDA 510(k) premarket notification submitted by Omnisonics Medical Technologies for the device "OMNISONICS ULTRASONIC SURGERY SYSTEM, MODEL STI". The FDA issued a decision of Substantially Equivalent on March 8, 2001. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Omnisonics Medical Technologies has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 2001
- Date Received
- December 11, 2000
- 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