Clearance Summary
PHARMA-PLAST SINGLE USE OVERSHOES received FDA 510(k) clearance under submission number K843475, sponsored by Zimmar Consulting , Ltd.. 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 1984-10-31.
- Submission: K843475
- Applicant / Sponsor: Zimmar Consulting , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1984-10-31
Classification & Regulation
This clearance is catalogued under FDA product code FXP and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.