Clearance Summary
DRUSHOE received FDA 510(k) clearance under submission number K790326, sponsored by J.E. Hanger & Co. , 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 1979-02-26.
- Submission: K790326
- Applicant / Sponsor: J.E. Hanger & Co. , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1979-02-26
Classification & Regulation
This clearance is catalogued under FDA product code KNP and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.