Cleared Traditional

ULTRACELL PACKING WITH SLEEVE

K973085 · Ultracell Medical Technologies, Inc. · Ear, Nose, Throat
Nov 1997
Decision
92d
Days
Class 1
Risk

About This 510(k) Submission

K973085 is an FDA 510(k) clearance for the ULTRACELL PACKING WITH SLEEVE, a Balloon, Epistaxis (Class I — General Controls, product code EMX), submitted by Ultracell Medical Technologies, Inc. (North Stonington, US). The FDA issued a Cleared decision on November 18, 1997, 92 days after receiving the submission on August 18, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4100.

Submission Details

510(k) Number K973085 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1997
Decision Date November 18, 1997
Days to Decision 92 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code EMX — Balloon, Epistaxis
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.4100

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