Cleared Traditional

Omnican fine

K173803 · B.Braun Medical, Inc. · General Hospital
Jun 2018
Decision
178d
Days
Class 2
Risk

About This 510(k) Submission

K173803 is an FDA 510(k) clearance for the Omnican fine, a Needle, Hypodermic, Single Lumen (Class II — Special Controls, product code FMI), submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on June 11, 2018, 178 days after receiving the submission on December 15, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K173803 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2017
Decision Date June 11, 2018
Days to Decision 178 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMI — Needle, Hypodermic, Single Lumen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5570

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