Clearance Summary
MATELAS COQUILLE LATTREDE TASSIGNY received FDA 510(k) clearance under submission number K811547, sponsored by Firn-France. 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 1981-06-18.
- Submission: K811547
- Applicant / Sponsor: Firn-France
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6900
- Decision date: 1981-06-18
Classification & Regulation
This clearance is catalogued under FDA product code FPP and 21 CFR 880.6900, within the General Hospital review panel as a Class I device.