Clearance Summary
SIL-MED T-TUBE DRAIN received FDA 510(k) clearance under submission number K903989, sponsored by Sil-Med Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1991-01-31.
- Submission: K903989
- Applicant / Sponsor: Sil-Med Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3200
- Decision date: 1991-01-31
Classification & Regulation
This clearance is catalogued under FDA product code HFL and 21 CFR 884.3200, within the Obstetrics/Gynecology review panel as a Class II device.