Clearance Summary
DRESSING CHANGE KIT received FDA 510(k) clearance under submission number K940069, sponsored by Mason-Keller Corp.. 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 1994-03-18.
- Submission: K940069
- Applicant / Sponsor: Mason-Keller Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1994-03-18
Classification & Regulation
This clearance is catalogued under FDA product code FYA and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.