510(k) K800448
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 5, 1980
- Date Received
- February 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Oral Irrigation
- Device Class
- Class I
- Regulation Number
- 872.6510
- Review Panel
- DE
- Submission Type