Clearance Summary
DERMATHERAPY, MODEL 22216 received FDA 510(k) clearance under submission number K061242, 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 2007-01-25.
- Submission: K061242
- 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: 2007-01-25
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.