Clearance Summary
STILLE SCANDIA OPERATING TABLES RC 3000,1100 received FDA 510(k) clearance under submission number K850168, sponsored by Stille-Werner (Usa), 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 1985-03-28.
- Submission: K850168
- Applicant / Sponsor: Stille-Werner (Usa), Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1985-03-28
Classification & Regulation
This clearance is catalogued under FDA product code GDC and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.