Cleared Traditional

MILL-ROSE BLIND MICROBIOLOGY BRUSH

K960880 · Mill-Rose Laboratory · Ear, Nose, Throat

Apr 1996

Decision

56d

Days

Class 2

Risk

About This 510(k) Submission

K960880 is an FDA 510(k) clearance for the MILL-ROSE BLIND MICROBIOLOGY 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 April 29, 1996, 56 days after receiving the submission on March 4, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K960880 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 04, 1996
Decision Date	April 29, 1996
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

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).