Clearance Summary
JAKOBI SURG. INSTRUMENTS #8 15 received FDA 510(k) clearance under submission number K834190, sponsored by Imm Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1984-03-06.
- Submission: K834190
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1984-03-06
Classification & Regulation
This clearance is catalogued under FDA product code EMH and 21 CFR 872.4565, within the Dental review panel as a Class I device.