Cleared Traditional

K962400 - AIR MAX EXTERNAL NASAL DILATOR STRIP
(FDA 510(k) Clearance)

K962400 · American White Cross, Inc. · Ear, Nose, Throat device

Sep 1996

Decision

80d

Days

Class 1

Risk

K962400 is an FDA 510(k) clearance for the AIR MAX EXTERNAL NASAL DILATOR STRIP. This device is classified as a Dilator, Nasal (Class I - General Controls, product code LWF).

Submitted by American White Cross, Inc. (Dayville, US). The FDA issued a Cleared decision on September 9, 1996, 80 days after receiving the submission on June 21, 1996.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3900.

Submission Details

510(k) Number	K962400 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 21, 1996
Decision Date	September 09, 1996
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement