510(k) K843017
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1985
- Date Received
- July 31, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Point, Paper, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.3830
- Review Panel
- DE
- Submission Type