Clearance Summary
EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES received FDA 510(k) clearance under submission number K864011, sponsored by Fraass Survival Systems, Inc.. 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 1986-11-22.
- Submission: K864011
- Applicant / Sponsor: Fraass Survival Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 1986-11-22
Classification & Regulation
This clearance is catalogued under FDA product code NAD and 21 CFR 878.4020, within the General, Plastic Surgery review panel as a Class I device.