Cleared Traditional

K982929 - MAXAIR NASAL DILATOR SYSTEM (FDA 510(k) Clearance)

K982929 · Hnl Technologies · Ear, Nose, Throat device

Sep 1998

Decision

20d

Days

Class 1

Risk

K982929 is an FDA 510(k) clearance for the MAXAIR NASAL DILATOR SYSTEM. This device is classified as a Dilator, Nasal (Class I - General Controls, product code LWF).

Submitted by Hnl Technologies (San Mateo, US). The FDA issued a Cleared decision on September 9, 1998, 20 days after receiving the submission on August 20, 1998.

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

Submission Details

510(k) Number	K982929 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 20, 1998
Decision Date	September 09, 1998
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement