Cleared Traditional

HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML

K142153 · Teleflexmedical, Inc. · Anesthesiology
Apr 2015
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K142153 is an FDA 510(k) clearance for the HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML, a Nebulizer (direct Patient Interface) (Class II — Special Controls, product code CAF), submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on April 29, 2015, 266 days after receiving the submission on August 6, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5630.

Submission Details

510(k) Number K142153 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2014
Decision Date April 29, 2015
Days to Decision 266 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAF — Nebulizer (direct Patient Interface)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5630

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