Clearance Summary
DONWAY SPLINT received FDA 510(k) clearance under submission number K843522, sponsored by Australian Biomedical Corporation , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1985-02-07.
- Submission: K843522
- Applicant / Sponsor: Australian Biomedical Corporation , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5900
- Decision date: 1985-02-07
Classification & Regulation
This clearance is catalogued under FDA product code ITH and 21 CFR 890.5900, within the Physical Medicine review panel as a Class II device.