Cleared Traditional

SAFE-T-SHIELD MOUTHPIECE

K865093 · Medi Nuclear Corp., Inc. · Anesthesiology
Jan 1987
Decision
16d
Days
Class 1
Risk

About This 510(k) Submission

K865093 is an FDA 510(k) clearance for the SAFE-T-SHIELD MOUTHPIECE, a Mouthpiece, Breathing (Class I — General Controls, product code BYP), submitted by Medi Nuclear Corp., Inc. (Baldwin Park, US). The FDA issued a Cleared decision on January 15, 1987, 16 days after receiving the submission on December 30, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5620.

Submission Details

510(k) Number K865093 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1986
Decision Date January 15, 1987
Days to Decision 16 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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