510(k) K140308
K140308 is an FDA 510(k) premarket notification submitted by Kaltenbach & Voigt GmbH for the device "MASTERSURG / EXPERTSURG". The FDA issued a decision of Substantially Equivalent on August 15, 2014. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. Kaltenbach & Voigt GmbH has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 15, 2014
- Date Received
- February 7, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Foot, Handpiece And Cord
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type