Cleared Traditional

PREFILLED RESPIRATORY THERAPY VIALS

K870332 · Automatic Liquid Packaging, Inc. · Anesthesiology
Apr 1987
Decision
63d
Days
Class 1
Risk

About This 510(k) Submission

K870332 is an FDA 510(k) clearance for the PREFILLED RESPIRATORY THERAPY VIALS, a Nebulizer, Medicinal, Non-ventilatory (atomizer) (Class I — General Controls, product code CCQ), submitted by Automatic Liquid Packaging, Inc. (Woodstock, US). The FDA issued a Cleared decision on April 1, 1987, 63 days after receiving the submission on January 28, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5640.

Submission Details

510(k) Number K870332 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 1987
Decision Date April 01, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CCQ — Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5640

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