510(k) K884937
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1989
- Date Received
- November 28, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Heat Source For Bleaching Teeth
- Device Class
- Class I
- Regulation Number
- 872.6475
- Review Panel
- DE
- Submission Type