510(k) K032925
K032925 is an FDA 510(k) premarket notification submitted by Ronvig A/S for the device "B&R DEVICE". The FDA issued a decision of Substantially Equivalent on Dec 22, 2003. The device falls under product code EGS (Handpiece, Contra- And Right-Angle Attachment, Dental), a Class I device regulated under 21 CFR 872.4200. Ronvig A/S has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 22, 2003
- Date Received
- Sep 22, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Handpiece, Contra- And Right-Angle Attachment, Dental
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type
- 510(k)