Clearance Summary
OP-CON SURGICAL INSTRUMENTS #4 received FDA 510(k) clearance under submission number K834173, sponsored by Imm Enterprises , Ltd.. 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 1983-12-27.
- Submission: K834173
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1983-12-27
Classification & Regulation
This clearance is catalogued under FDA product code LBX and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.