Cleared Traditional

NASAL OXYGEN CANNULA, 81585, 81587 & 81589

K913421 · Specialty Packaging Producs, Inc. · Anesthesiology
Oct 1991
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K913421 is an FDA 510(k) clearance for the NASAL OXYGEN CANNULA, 81585, 81587 & 81589, a Cannula, Nasal, Oxygen (Class I — General Controls, product code CAT), submitted by Specialty Packaging Producs, Inc. (El Paso, US). The FDA issued a Cleared decision on October 18, 1991, 79 days after receiving the submission on July 31, 1991. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5340.

Submission Details

510(k) Number K913421 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 1991
Decision Date October 18, 1991
Days to Decision 79 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement

Device Classification

Product Code CAT — Cannula, Nasal, Oxygen
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5340

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