Clearance Summary
XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and received FDA 510(k) clearance under submission number K142646, sponsored by Genadyne Biotechnologies, 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 2015-04-30.
- Submission: K142646
- Applicant / Sponsor: Genadyne Biotechnologies, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 2015-04-30
Classification & Regulation
This clearance is catalogued under FDA product code OMP and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.