Cleared Traditional

IRRIGATION BOTTLE

K973829 · Automatic Liquid Packaging, Inc. · Anesthesiology
Feb 1998
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K973829 is an FDA 510(k) clearance for the IRRIGATION BOTTLE, 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 February 23, 1998, 139 days after receiving the submission on October 7, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K973829 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1997
Decision Date February 23, 1998
Days to Decision 139 days
Submission Type Traditional
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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