Cleared Traditional

K900456 - POLAMEDCO NASOPAHARYNGEAL AIRWAY
(FDA 510(k) Clearance)

Apr 1990
Decision
79d
Days
Class 1
Risk

K900456 is an FDA 510(k) clearance for the POLAMEDCO NASOPAHARYNGEAL AIRWAY. This device is classified as a Airway, Nasopharyngeal (Class I - General Controls, product code BTQ).

Submitted by Polamedco, Inc. (Inglewood, US). The FDA issued a Cleared decision on April 19, 1990, 79 days after receiving the submission on January 30, 1990.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5100.

Submission Details

510(k) Number K900456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date April 19, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BTQ — Airway, Nasopharyngeal
Device Class Class I - General Controls
CFR Regulation 21 CFR 868.5100

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