Cleared Traditional

MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT

K895502 · Microbio-Medics, Inc. · Ear, Nose, Throat
Dec 1989
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K895502 is an FDA 510(k) clearance for the MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT, a Splint, Nasal (Class I — General Controls, product code EPP), submitted by Microbio-Medics, Inc. (Columbus, US). The FDA issued a Cleared decision on December 8, 1989, 87 days after receiving the submission on September 12, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5800.

Submission Details

510(k) Number K895502 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 1989
Decision Date December 08, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

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

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