Clearance Summary
OLYMPIQUE MEDICAL SUPPORT HOSE AND STOCKINGS received FDA 510(k) clearance under submission number K964103, sponsored by Tournier-Bottu S.A.. 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 1997-01-06.
- Submission: K964103
- Applicant / Sponsor: Tournier-Bottu S.A.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5780
- Decision date: 1997-01-06
Classification & Regulation
This clearance is catalogued under FDA product code DWL and 21 CFR 880.5780, within the General Hospital review panel as a Class II device.