K250390
- 510(k) number
- K250390
- Device name
- CloSYS® Dry Mouth Sensitive Mouth Rinse
- Applicant
- Rowpar Pharmaceuticals, Inc. NJ · US
- Product code
- LFD — Saliva, Artificial
- Decision date
- 2025-05-19
- Date received
- 2025-02-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
510(k) Summary (official FDA PDF): K250390.pdf
Official FDA record: K250390
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.