Clearance Summary
SURGICAL LOUPES received FDA 510(k) clearance under submission number K891895, sponsored by Zinnanti Surgical Instruments, 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 1989-04-12.
- Submission: K891895
- Applicant / Sponsor: Zinnanti Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1989-04-12
Classification & Regulation
This clearance is catalogued under FDA product code FSP and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.