Cleared Traditional

EXTERNAL NASAL SPLINT

K942724 · Micromed Development Corp. · Ear, Nose, Throat
Jul 1994
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K942724 is an FDA 510(k) clearance for the EXTERNAL NASAL SPLINT, a Splint, Nasal (Class I — General Controls, product code EPP), submitted by Micromed Development Corp. (Clearwater, US). The FDA issued a Cleared decision on July 8, 1994, 29 days after receiving the submission on June 9, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5800.

Submission Details

510(k) Number K942724 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1994
Decision Date July 08, 1994
Days to Decision 29 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code EPP — Splint, Nasal
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5800

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