Clearance Summary
SILICONE SUMP DRAIN received FDA 510(k) clearance under submission number K862767, 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 1986-08-07.
- Submission: K862767
- 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: 1986-08-07
Classification & Regulation
This clearance is catalogued under FDA product code GBS and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.