Clearance Summary
MEDTRADE PRODICT'S SOOTHING GEL PATCH received FDA 510(k) clearance under submission number K030901, sponsored by Medtrade Products , Ltd.. 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 2004-11-26.
- Submission: K030901
- Applicant / Sponsor: Medtrade Products , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5630
- Decision date: 2004-11-26
Classification & Regulation
This clearance is catalogued under FDA product code NTC and 21 CFR 880.5630, within the General Hospital review panel as a Class I device.