Clearance Summary
JAKOBI SURG. INSTRUMENTS #6 50 received FDA 510(k) clearance under submission number K834187, sponsored by Imm Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-03-05.
- Submission: K834187
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1930
- Decision date: 1984-03-05
Classification & Regulation
This clearance is catalogued under FDA product code HKY and 21 CFR 886.1930, within the Ophthalmic review panel as a Class II device.