510(k) K042822
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2004
- Date Received
- October 12, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type