Cleared Traditional

GRIESHABER AIR/FLUID TUBING SET

K914587 · Grieshaber & Co. · Ophthalmic
Jan 1992
Decision
99d
Days
Class 1
Risk

About This 510(k) Submission

K914587 is an FDA 510(k) clearance for the GRIESHABER AIR/FLUID TUBING SET, a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by Grieshaber & Co. (Langhorne, US). The FDA issued a Cleared decision on January 23, 1992, 99 days after receiving the submission on October 16, 1991. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number K914587 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 1991
Decision Date January 23, 1992
Days to Decision 99 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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