Cleared Traditional

K924944 - INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA
(FDA 510(k) Clearance)

K924944 · Westmed Intl. · Ear, Nose, Throat

Jul 1993

Decision

275d

Days

Class 1

Risk

K924944 is an FDA 510(k) clearance for the INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA. This device is classified as a Balloon, Epistaxis (Class I — General Controls, product code EMX).

Submitted by Westmed Intl. (Tucson, US). The FDA issued a Cleared decision on July 2, 1993, 275 days after receiving the submission on September 30, 1992.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4100.

Submission Details

510(k) Number	K924944 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 1992
Decision Date	July 02, 1993
Days to Decision	275 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement