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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilizer, steam
510(k) Number K163337
Device Name Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D AutoClave® Automatic Sterilizer
Applicant
Midmark Corporation
60 VISTA DR.
VERSAILLES,  OH  45380
Applicant Contact ADAM CLUTTER
Correspondent
Midmark Corporation
60 VISTA DR.
VERSAILLES,  OH  45380
Correspondent Contact ADAM CLUTTER
Regulation Number880.6880
Classification Product Code
FLE  
Date Received11/28/2016
Decision Date 08/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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