Cleared Traditional

K962698 - ACUTEK'S CLEARPASAGE (FDA 510(k) Clearance)

K962698 · Acutek Adhesive Specialties, Inc. · Ear, Nose, Throat device

Sep 1996

Decision

84d

Days

Class 1

Risk

K962698 is an FDA 510(k) clearance for the ACUTEK'S CLEARPASAGE. This device is classified as a Dilator, Nasal (Class I - General Controls, product code LWF).

Submitted by Acutek Adhesive Specialties, Inc. (Inglewood, US). The FDA issued a Cleared decision on September 9, 1996, 84 days after receiving the submission on June 17, 1996.

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

Submission Details

510(k) Number	K962698 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 17, 1996
Decision Date	September 09, 1996
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement