Clearance Summary
3M COMPLY 1248 GAS PLASMA CHEMICAL INDICATOR received FDA 510(k) clearance under submission number K013228, sponsored by Minnesota Mining and Mfg. Co.. 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 2002-01-18.
- Submission: K013228
- Applicant / Sponsor: Minnesota Mining and Mfg. Co.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2002-01-18
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.