Cleared Traditional

SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE

K912418 · Micromedics, Inc. · General & Plastic Surgery
Dec 1991
Decision
203d
Days
Class 1
Risk

About This 510(k) Submission

K912418 is an FDA 510(k) clearance for the SHIKANI MIDDLE MEATAL ANTROSTOMY VENT TUBE, a Cannula, Sinus (Class I — General Controls, product code KAM), submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 20, 1991, 203 days after receiving the submission on May 31, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K912418 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 1991
Decision Date December 20, 1991
Days to Decision 203 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code KAM — Cannula, Sinus
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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