Cleared Traditional

MOISTAIR FLUID AIR TUBING SET

K974561 · American Medical Devices, Inc. · Ophthalmic
Feb 1998
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K974561 is an FDA 510(k) clearance for the MOISTAIR FLUID AIR TUBING SET, a Device, Irrigation, Ocular Surgery (Class I — General Controls, product code KYG), submitted by American Medical Devices, Inc. (Atlanta, US). The FDA issued a Cleared decision on February 19, 1998, 76 days after receiving the submission on December 5, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4360.

Submission Details

510(k) Number K974561 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 1997
Decision Date February 19, 1998
Days to Decision 76 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

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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