510(k) K972148
K972148 is an FDA 510(k) premarket notification submitted by Medicamat S.A. for the device "B.U.S. ENDOTRON". The FDA issued a decision of Substantially Equivalent on December 10, 1997. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Medicamat S.A. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 10, 1997
- Date Received
- June 9, 1997
- 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