Cleared Traditional

I/V POLE

K935226 · Optical Micro Systems, Inc. · Ophthalmic
Feb 1994
Decision
107d
Days
Class 1
Risk

About This 510(k) Submission

K935226 is an FDA 510(k) clearance for the I/V POLE, a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by Optical Micro Systems, Inc. (Waterford, US). The FDA issued a Cleared decision on February 16, 1994, 107 days after receiving the submission on November 1, 1993. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number K935226 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1993
Decision Date February 16, 1994
Days to Decision 107 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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