Cleared Traditional

MED-LOGICS DISPOSABLE ALK TUBING

K010353 · Med-Logics, Inc. · Ophthalmic
Apr 2001
Decision
80d
Days
Class 1
Risk

About This 510(k) Submission

K010353 is an FDA 510(k) clearance for the MED-LOGICS DISPOSABLE ALK TUBING, a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by Med-Logics, Inc. (Laguna Niguel,, US). The FDA issued a Cleared decision on April 27, 2001, 80 days after receiving the submission on February 6, 2001. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number K010353 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 2001
Decision Date April 27, 2001
Days to Decision 80 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

Product Code KYG — Device, Irrigation, Ocular Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4360

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