Clearance Summary
DermaTherapy Bed Linens received FDA 510(k) clearance under submission number K152884, sponsored by Precision Fabrics Group, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-06-20.
- Submission: K152884
- Applicant / Sponsor: Precision Fabrics Group, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6190
- Decision date: 2016-06-20
Classification & Regulation
This clearance is catalogued under FDA product code FMW and 21 CFR 880.6190, within the General Hospital review panel as a Class I device.