Clearance Summary
MULAR GOLD LEAF ELECTRODE MODEL 7501 received FDA 510(k) clearance under submission number K781476, sponsored by Life-Tech Instruments, 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 1978-11-15.
- Submission: K781476
- Applicant / Sponsor: Life-Tech Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.1220
- Decision date: 1978-11-15
Classification & Regulation
This clearance is catalogued under FDA product code HLZ and 21 CFR 886.1220, within the Ophthalmic review panel as a Class II device.