Clearance Summary
SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR received FDA 510(k) clearance under submission number K961295, 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 1996-06-26.
- Submission: K961295
- 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: 1996-06-26
Classification & Regulation
This clearance is catalogued under FDA product code GBX and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.