Cleared Special

STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109

K000964 · Automatic Liquid Packaging, Inc. · Anesthesiology
Apr 2000
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K000964 is an FDA 510(k) clearance for the STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109, a Tube Tracheostomy And Tube Cuff (Class II — Special Controls, product code JOH), submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on April 25, 2000, 29 days after receiving the submission on March 27, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K000964 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2000
Decision Date April 25, 2000
Days to Decision 29 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code JOH — Tube Tracheostomy And Tube Cuff
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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