Clearance Summary
OP-CON SURGICAL INSTRUMENT #9 received FDA 510(k) clearance under submission number K834540, sponsored by Imm Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1984-03-06.
- Submission: K834540
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 1984-03-06
Classification & Regulation
This clearance is catalogued under FDA product code KBN and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.