Clearance Summary
SAME/VARIOUS DISTRIBUTORS/WE MAY PRIVATE LABEL received FDA 510(k) clearance under submission number K112743, sponsored by Clean Medical Manfacturing Co;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 2011-12-16.
- Submission: K112743
- Applicant / Sponsor: Clean Medical Manfacturing Co;Ltd
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6250
- Decision date: 2011-12-16
Classification & Regulation
This clearance is catalogued under FDA product code LYZ and 21 CFR 880.6250, within the General Hospital review panel as a Class I device.