Clearance Summary
PCI CUSTOM DESIGN SERIES received FDA 510(k) clearance under submission number K861943, sponsored by Poston & Cole Intl.. 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 1986-05-30.
- Submission: K861943
- Applicant / Sponsor: Poston & Cole Intl.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.3880
- Decision date: 1986-05-30
Classification & Regulation
This clearance is catalogued under FDA product code IQC and 21 CFR 890.3880, within the Physical Medicine review panel as a Class II device.