Clearance Summary
PROVIDONE-IODINE PREP-PADS & TOWELETTES received FDA 510(k) clearance under submission number K830394, sponsored by H & P Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1983-04-06.
- Submission: K830394
- Applicant / Sponsor: H & P Industries, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1983-04-06
Classification & Regulation
This clearance is catalogued under FDA product code GEC and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.