Cleared Traditional

WEE BAG O'MERCURY

K946194 · Microsurgical Technology, Inc. · Ophthalmic
Feb 1995
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K946194 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 Microsurgical Technology, Inc. (Kirkland, US). The FDA issued a Cleared decision on February 27, 1995, 69 days after receiving the submission on December 20, 1994. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4610.

Submission Details

510(k) Number K946194 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1994
Decision Date February 27, 1995
Days to Decision 69 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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