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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Cleaning, For Endoscope
510(k) Number K060458
Device Name MANZI MACH 1 INSTRUMENT CLEANER-PROCESSOR SYSTEM, MANZI DETERGENT MD10, MANZI STERILANT MS10, MANZI CHEMICAL INDICATOR
Applicant
LANGFORD IC SYSTEMS, INC.
141 WASHINGTON STREET
EAST WALPOLE,  MA  02032
Applicant Contact JIMMIE T JOHNSTON
Correspondent
LANGFORD IC SYSTEMS, INC.
141 WASHINGTON STREET
EAST WALPOLE,  MA  02032
Correspondent Contact JIMMIE T JOHNSTON
Regulation Number876.1500
Classification Product Code
FEB  
Date Received02/22/2006
Decision Date 10/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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