Clearance Summary
MARC MEDICAL PROBE COVER-200 received FDA 510(k) clearance under submission number K850424, sponsored by K&M Plastics. 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 1985-05-15.
- Submission: K850424
- Applicant / Sponsor: K&M Plastics
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 1985-05-15
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.