Clearance Summary
LM-1Z ZOOM SCOPE received FDA 510(k) clearance under submission number K902313, sponsored by Leisegang Medical, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1990-09-04.
- Submission: K902313
- Applicant / Sponsor: Leisegang Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1630
- Decision date: 1990-09-04
Classification & Regulation
This clearance is catalogued under FDA product code HEX and 21 CFR 884.1630, within the Obstetrics/Gynecology review panel as a Class II device.