Clearance Summary
WEE BAG O'MERCURY received FDA 510(k) clearance under submission number K840004, sponsored by Surgi-Quip Inc.U. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1984-03-22.
- Submission: K840004
- Applicant / Sponsor: Surgi-Quip Inc.U
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4610
- Decision date: 1984-03-22
Classification & Regulation
This clearance is catalogued under FDA product code LCC and 21 CFR 886.4610, within the Ophthalmic review panel as a Class II device.