Clearance Summary
FOAMIES DIAPOS. FOAM RUBBER PADS received FDA 510(k) clearance under submission number K830601, sponsored by Precision Cap Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1983-03-24.
- Submission: K830601
- Applicant / Sponsor: Precision Cap Systems
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1320
- Decision date: 1983-03-24
Classification & Regulation
This clearance is catalogued under FDA product code GXY and 21 CFR 882.1320, within the Neurology review panel as a Class II device.