Clearance Summary
MONOJECT SCALE MAGNIFIER received FDA 510(k) clearance under submission number K781459, sponsored by Sherwood Medical Industries. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1978-10-24.
- Submission: K781459
- Applicant / Sponsor: Sherwood Medical Industries
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5800
- Decision date: 1978-10-24
Classification & Regulation
This clearance is catalogued under FDA product code HJY and 21 CFR 886.5800, within the Ophthalmic review panel as a Class I device.