Clearance Summary
ERG-JET ELECTRODE received FDA 510(k) clearance under submission number K823767, sponsored by Life-Tech Intl., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1983-01-08.
- Submission: K823767
- Applicant / Sponsor: Life-Tech Intl., Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.1430
- Decision date: 1983-01-08
Classification & Regulation
This clearance is catalogued under FDA product code HLF and 21 CFR 886.1430, within the Ophthalmic review panel as a Class I device.