Clearance Summary
MULTI-WASH received FDA 510(k) clearance under submission number K950324, sponsored by Multi-Wash Medical, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1995-03-22.
- Submission: K950324
- Applicant / Sponsor: Multi-Wash Medical, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6890
- Decision date: 1995-03-22
Classification & Regulation
This clearance is catalogued under FDA product code LRJ and 21 CFR 880.6890, within the General Hospital review panel as a Class I device.