Cleared Traditional

ML UNIVERSAL TUBING

K983448 · Med-Logics, Inc. · Ophthalmic
Dec 1998
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K983448 is an FDA 510(k) clearance for the ML UNIVERSAL TUBING, a Tubing, Replacement, Phacofragmentation Unit (Class II — Special Controls, product code MSR), submitted by Med-Logics, Inc. (Laguna Niguel, US). The FDA issued a Cleared decision on December 18, 1998, 79 days after receiving the submission on September 30, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K983448 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1998
Decision Date December 18, 1998
Days to Decision 79 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code MSR — Tubing, Replacement, Phacofragmentation Unit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4150