Cleared Traditional

MILL-ROSE RIGID SCOPE CLEANING BRUSHES

K954745 · Mill-Rose Laboratory · General Hospital

Nov 1995

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K954745 is an FDA 510(k) clearance for the MILL-ROSE RIGID SCOPE CLEANING BRUSHES, a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on November 27, 1995, 42 days after receiving the submission on October 16, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K954745 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 16, 1995
Decision Date	November 27, 1995
Days to Decision	42 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	FEB — Accessories, Cleaning, For Endoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	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).