510(k) K050895
K050895 is an FDA 510(k) premarket notification submitted by Satelec for the device "SURPASSON P5 NEWTRON". The FDA issued a decision of Substantially Equivalent on April 20, 2005. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Satelec has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2005
- Date Received
- April 8, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Scaler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 872.4850
- Review Panel
- DE
- Submission Type