Clearance Summary
PALMER OBSTETIC BRACE received FDA 510(k) clearance under submission number K844183, sponsored by Mic Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1985-02-04.
- Submission: K844183
- Applicant / Sponsor: Mic Medical Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1985-02-04
Classification & Regulation
This clearance is catalogued under FDA product code KNC and 21 CFR 884.4900, within the Obstetrics/Gynecology review panel as a Class II device.