510(k) K052518
K052518 is an FDA 510(k) premarket notification submitted by Piezosurgery S.R.L. for the device "PIEZOSURGERY". The FDA issued a decision of Substantially Equivalent on November 16, 2005. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Piezosurgery S.R.L. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2005
- Date Received
- September 14, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type