Clearance Summary
DECONTAMINATING KIT, SKIN: M291 received FDA 510(k) clearance under submission number K894455, sponsored by Dept. of the Army. 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 1989-08-15.
- Submission: K894455
- Applicant / Sponsor: Dept. of the Army
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4014
- Decision date: 1989-08-15
Classification & Regulation
This clearance is catalogued under FDA product code MAC and 21 CFR 878.4014, within the General, Plastic Surgery review panel as a Class I device.