Cleared Traditional

K901279 - CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY
(FDA 510(k) Clearance)

Mar 1990
Decision
9d
Days
Class 1
Risk

K901279 is an FDA 510(k) clearance for the CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY. This device is classified as a Airway, Nasopharyngeal (Class I - General Controls, product code BTQ).

Submitted by Chatham Industries (Summit, US). The FDA issued a Cleared decision on March 28, 1990, 9 days after receiving the submission on March 19, 1990.

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

Submission Details

510(k) Number K901279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1990
Decision Date March 28, 1990
Days to Decision 9 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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