Clearance Summary
H.R. JAKOBI SURG. INSTRUMENTS #9 48 received FDA 510(k) clearance under submission number K834179, sponsored by Imm Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 1984-01-27.
- Submission: K834179
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.5800
- Decision date: 1984-01-27
Classification & Regulation
This clearance is catalogued under FDA product code BTO and 21 CFR 868.5800, within the Anesthesiology review panel as a Class II device.