510(k) K021258
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2002
- Date Received
- April 19, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile
- Device Class
- Class I
- Regulation Number
- 872.6855
- Review Panel
- DE
- Submission Type