510(k) K092917
K092917 is an FDA 510(k) premarket notification submitted by Cefla S.C. for the device "STERN'S S250 NORDAM". The FDA issued a decision of Substantially Equivalent on June 24, 2010. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. Cefla S.C. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 24, 2010
- Date Received
- September 22, 2009
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Operative Dental
- Device Class
- Class I
- Regulation Number
- 872.6640
- Review Panel
- DE
- Submission Type