Clearance Summary
QMT NIMBUS ANTIMICROBIAL BARRIER GAUZE DRESSING received FDA 510(k) clearance under submission number DEN070002, sponsored by Quick-Med Technologies, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-02-25.
- Submission: DEN070002
- Applicant / Sponsor: Quick-Med Technologies, Inc.
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4015
- Decision date: 2009-02-25
Classification & Regulation
This clearance is catalogued under FDA product code NYS and 21 CFR 878.4015, within the General, Plastic Surgery review panel as a Class II device.