Clearance Summary
AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 received FDA 510(k) clearance under submission number K880588, sponsored by C.I.S.A. Import Export C/O Larson and Taylor. 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 1988-12-20.
- Submission: K880588
- Applicant / Sponsor: C.I.S.A. Import Export C/O Larson and Taylor
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1988-12-20
Classification & Regulation
This clearance is catalogued under FDA product code HIB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.