Clearance Summary
PALMER OBSTETRIC BRACE received FDA 510(k) clearance under submission number K864194, sponsored by Ad-Tech Medical Instrument 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 1987-01-14.
- Submission: K864194
- Applicant / Sponsor: Ad-Tech Medical Instrument Corp
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4900
- Decision date: 1987-01-14
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.