510(k) K953192
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 1995
- Date Received
- June 23, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Fiber Optic, Dental
- Device Class
- Class I
- Regulation Number
- 872.4620
- Review Panel
- DE
- Submission Type