510(k) K030895
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2003
- Date Received
- March 21, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Root Apex
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type