Cleared Traditional

EZ-MISTER

K093584 · N.M. Beale Co., Inc. · Anesthesiology
Mar 2011
Decision
470d
Days
Class 2
Risk

About This 510(k) Submission

K093584 is an FDA 510(k) clearance for the EZ-MISTER, a Applicator (laryngo-tracheal), Topical Anesthesia (Class II — Special Controls, product code CCT), submitted by N.M. Beale Co., Inc. (Ayer, US). The FDA issued a Cleared decision on March 4, 2011, 470 days after receiving the submission on November 19, 2009. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5170.

Submission Details

510(k) Number K093584 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2009
Decision Date March 04, 2011
Days to Decision 470 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CCT — Applicator (laryngo-tracheal), Topical Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5170

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