Cleared Traditional

ML DISPOSABLE ALK TUBING

K971173 · Med-Logics, Inc. · Ophthalmic
May 1997
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K971173 is an FDA 510(k) clearance for the ML DISPOSABLE ALK TUBING, a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by Med-Logics, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on May 22, 1997, 52 days after receiving the submission on March 31, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number K971173 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 1997
Decision Date May 22, 1997
Days to Decision 52 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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