Clearance Summary
IMPERVIOUS ISOLATION SHOE COVERS received FDA 510(k) clearance under submission number K923187, sponsored by Dynatech Medical Products. 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 1993-01-29.
- Submission: K923187
- Applicant / Sponsor: Dynatech Medical Products
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4040
- Decision date: 1993-01-29
Classification & Regulation
This clearance is catalogued under FDA product code FXW and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class I device.