Cleared Traditional

ML-DISPOSABLE PAK

K972522 · Med-Logics, Inc. · Ophthalmic
Sep 1997
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K972522 is an FDA 510(k) clearance for the ML-DISPOSABLE PAK, a Tubing, Replacement, Phacofragmentation Unit (Class II — Special Controls, product code MSR), submitted by Med-Logics, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on September 30, 1997, 85 days after receiving the submission on July 7, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.

Submission Details

510(k) Number K972522 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 1997
Decision Date September 30, 1997
Days to Decision 85 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