Cleared Traditional

MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT

K860940 · Micromedics, Inc. · Ear, Nose, Throat
May 1986
Decision
51d
Days
Class 1
Risk

About This 510(k) Submission

K860940 is an FDA 510(k) clearance for the MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT, a Unit, Examining/treatment, Ent (Class I — General Controls, product code ETF), submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 2, 1986, 51 days after receiving the submission on March 12, 1986. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5300.

Submission Details

510(k) Number K860940 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1986
Decision Date May 02, 1986
Days to Decision 51 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ETF — Unit, Examining/treatment, Ent
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5300

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