Cleared Traditional

MP-4400 MOUTHPIECE-FLANGE SEAL

K862788 · Medipart Jerry Alexander · Anesthesiology
Aug 1986
Decision
9d
Days
Class 1
Risk

About This 510(k) Submission

K862788 is an FDA 510(k) clearance for the MP-4400 MOUTHPIECE-FLANGE SEAL, a Mouthpiece, Breathing (Class I — General Controls, product code BYP), submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on August 1, 1986, 9 days after receiving the submission on July 23, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5620.

Submission Details

510(k) Number K862788 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1986
Decision Date August 01, 1986
Days to Decision 9 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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