510(k) K203567
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2021
- Date Received
- December 7, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Saliva, Artificial
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type