510(k) K080631
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2008
- Date Received
- March 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleanser, Denture, Over The Counter
- Device Class
- Class I
- Regulation Number
- 872.3520
- Review Panel
- DE
- Submission Type