Cleared Traditional

49-610 NIKO-NOSE FIXATION TAPE

K902896 · Nikomed U.S.A., Inc. · Anesthesiology
Oct 1990
Decision
112d
Days
Class 1
Risk

About This 510(k) Submission

K902896 is an FDA 510(k) clearance for the 49-610 NIKO-NOSE FIXATION TAPE, a Device, Fixation, Tracheal Tube (Class I — General Controls, product code CBH), submitted by Nikomed U.S.A., Inc. (North Brunswick, US). The FDA issued a Cleared decision on October 23, 1990, 112 days after receiving the submission on July 3, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5770.

Submission Details

510(k) Number K902896 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1990
Decision Date October 23, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CBH — Device, Fixation, Tracheal Tube
Device Class Class I — General Controls
CFR Regulation 21 CFR 868.5770

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