Cleared Traditional

K060458 - MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR
(FDA 510(k) Clearance)

K060458 · Langford IC Systems, Inc. · General Hospital

Oct 2006

Decision

232d

Days

Class 2

Risk

K060458 is an FDA 510(k) clearance for the MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR, a Accessories, Cleaning, For Endoscope (Class II — Special Controls, product code FEB), submitted by Langford IC Systems, Inc. (East Walpole, US). The FDA issued a Cleared decision on October 12, 2006, 232 days after receiving the submission on February 22, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K060458 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2006
Decision Date	October 12, 2006
Days to Decision	232 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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).