Cleared Traditional

K862903 - MIDDLE EAR VIEWER AND FLUID COLLECTOR
(FDA 510(k) Clearance)

K862903 · Steven K. Juhn · Ear, Nose, Throat device

Nov 1986

Decision

116d

Days

Class 1

Risk

K862903 is an FDA 510(k) clearance for the MIDDLE EAR VIEWER AND FLUID COLLECTOR. This device is classified as a Tube, Ear Suction (Class I - General Controls, product code JZF).

Submitted by Steven K. Juhn (Minneapolis, US). The FDA issued a Cleared decision on November 24, 1986, 116 days after receiving the submission on July 31, 1986.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K862903 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 31, 1986
Decision Date	November 24, 1986
Days to Decision	116 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—