Clearance Summary
MALIS SURGICAL LOUPES received FDA 510(k) clearance under submission number K874845, sponsored by Valley Forge Scientific Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1987-12-23.
- Submission: K874845
- Applicant / Sponsor: Valley Forge Scientific Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.5120
- Decision date: 1987-12-23
Classification & Regulation
This clearance is catalogued under FDA product code HJH and 21 CFR 886.5120, within the Ophthalmic review panel as a Class I device.