510(k) K002708
K002708 is an FDA 510(k) premarket notification submitted by Kavo America for the device "KAVO CORUND HANDPIECE 2013". The FDA issued a decision of Substantially Equivalent on Nov 28, 2000. The device falls under product code KOJ (Airbrush), a Class II device regulated under 21 CFR 872.6080. Kavo America has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 28, 2000
- Date Received
- Aug 30, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Airbrush
- Device Class
- Class II
- Regulation Number
- 872.6080
- Review Panel
- DE
- Submission Type
- 510(k)