Clearance Summary
STAY FRESH SKIN FOLD MANAGEMENT TEXTILE received FDA 510(k) clearance under submission number K121898, sponsored by Quick-Med Technologies, 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 2013-05-24.
- Submission: K121898
- Applicant / Sponsor: Quick-Med Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5300
- Decision date: 2013-05-24
Classification & Regulation
This clearance is catalogued under FDA product code FRL and 21 CFR 880.5300, within the General Hospital review panel as a Class I device.