Clearance Summary
SILCLEAR TUBING received FDA 510(k) clearance under submission number K943992, 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 1995-03-16.
- Submission: K943992
- Applicant / Sponsor: Degania Silicone , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 1995-03-16
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.