Clearance Summary
MOBILE OPERATING TABLE FOR ORL MICROSURGERY received FDA 510(k) clearance under submission number K853720, sponsored by Carl Zeiss, 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 1985-10-18.
- Submission: K853720
- Applicant / Sponsor: Carl Zeiss, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1985-10-18
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.