Clearance Summary
SILON SILICONE TEXTILE COMPOSITE received FDA 510(k) clearance under submission number K952546, sponsored by Bio Med Sciences, Inc.. 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 1995-08-07.
- Submission: K952546
- Applicant / Sponsor: Bio Med Sciences, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 1995-08-07
Classification & Regulation
This clearance is catalogued under FDA product code MDA and 21 CFR 878.4025, within the General, Plastic Surgery review panel as a Class I device.