Cleared Traditional

MILL-ROSE HARRELL BRONCHIAL BRUSH

K944649 · Mill-Rose Laboratory · Ear, Nose, Throat

Nov 1994

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K944649 is an FDA 510(k) clearance for the MILL-ROSE HARRELL BRONCHIAL BRUSH, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on November 30, 1994, 70 days after receiving the submission on September 21, 1994. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K944649 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 1994
Decision Date	November 30, 1994
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	EOQ — Bronchoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).