Clearance Summary
REACTIVE SKIN DECONTAMINATION LOTION received FDA 510(k) clearance under submission number K023969, 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 2003-03-25.
- Submission: K023969
- 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: 2003-03-25
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.