Clearance Summary
FLUOROFILM(R) received FDA 510(k) clearance under submission number K933800, sponsored by American Custom Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1994-06-24.
- Submission: K933800
- Applicant / Sponsor: American Custom Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4100
- Decision date: 1994-06-24
Classification & Regulation
This clearance is catalogued under FDA product code EMX and 21 CFR 874.4100, within the Ear, Nose, Throat review panel as a Class I device.