Clearance Summary
MEDIASTINAL SILICONE DRAINS received FDA 510(k) clearance under submission number K942709, sponsored by Sil-Med Corp.. 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 1996-01-04.
- Submission: K942709
- Applicant / Sponsor: Sil-Med Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1996-01-04
Classification & Regulation
This clearance is catalogued under FDA product code GBW and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.