510(k) K964976
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 1997
- Date Received
- December 12, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Floss, Dental
- Device Class
- Class I
- Regulation Number
- 872.6390
- Review Panel
- DE
- Submission Type