Clearance Summary
DEGANIA SILICONE TOURNIQUET received FDA 510(k) clearance under submission number K875092, sponsored by Degania Silicone , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-01-07.
- Submission: K875092
- Applicant / Sponsor: Degania Silicone , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5900
- Decision date: 1988-01-07
Classification & Regulation
This clearance is catalogued under FDA product code GAX and 21 CFR 878.5900, within the General, Plastic Surgery review panel as a Class I device.