Cleared Traditional

K790931 - CORRUGATED TUBE WITH MOUTHPIECE
(FDA 510(k) Clearance)

K790931 · Mem Medical, Inc. · Anesthesiology
May 1979
Decision
6d
Days
Class 1
Risk

K790931 is an FDA 510(k) clearance for the CORRUGATED TUBE WITH MOUTHPIECE. This device is classified as a Mouthpiece, Breathing (Class I — General Controls, product code BYP).

Submitted by Mem Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1979, 6 days after receiving the submission on May 15, 1979.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5620.

Submission Details

510(k) Number K790931 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1979
Decision Date May 21, 1979
Days to Decision 6 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary

Device Classification

Product Code BYP — Mouthpiece, Breathing
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5620

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