Clearance Summary
SILCLEAR TUBING (MODIFICATION) received FDA 510(k) clearance under submission number K953864, sponsored by Degania Silicone , Ltd.. 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 1995-11-06.
- Submission: K953864
- Applicant / Sponsor: Degania Silicone , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1995-11-06
Classification & Regulation
This clearance is catalogued under FDA product code FPK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.