Cleared Traditional

WEE BAG O'MERCURY

K840004 · Surgi-Quip Inc.U · Ophthalmic
Mar 1984
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K840004 is an FDA 510(k) clearance for the WEE BAG O'MERCURY, a Applicator, Ocular Pressure (Class II — Special Controls, product code LCC), submitted by Surgi-Quip Inc.U (Mchenry, US). The FDA issued a Cleared decision on March 22, 1984, 78 days after receiving the submission on January 4, 1984. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4610.

Submission Details

510(k) Number K840004 FDA.gov
FDA Decision Cleared SESE
Date Received January 04, 1984
Decision Date March 22, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code LCC — Applicator, Ocular Pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4610