Cleared Traditional

MICROMEDICS EAR, NOSE AND THROAT BURS

K895738 · Micromedics, Inc. · Ear, Nose, Throat

Dec 1989

Decision

84d

Days

Class 1

Risk

About This 510(k) Submission

K895738 is an FDA 510(k) clearance for the MICROMEDICS EAR, NOSE AND THROAT BURS, a Bur, Ear, Nose And Throat (Class I — General Controls, product code EQJ), submitted by Micromedics, Inc. (St. Paul, US). The FDA issued a Cleared decision on December 19, 1989, 84 days after receiving the submission on September 26, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4140.

Submission Details

510(k) Number	K895738 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 1989
Decision Date	December 19, 1989
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—