Clearance Summary
OP-CON SURG. INSTRUMENT #10 received FDA 510(k) clearance under submission number K834170, sponsored by Imm Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 1984-02-23.
- Submission: K834170
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class I
- Regulation citation: 21 CFR 882.1700
- Decision date: 1984-02-23
Classification & Regulation
This clearance is catalogued under FDA product code GWZ and 21 CFR 882.1700, within the Neurology review panel as a Class I device.