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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Pasteurization, Hot Water
510(k) Number K183444
Device Name Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector
Applicant
Cenorin, LLC
6324 South 199th Place
Suite 107
Kent,  WA  98032
Applicant Contact Jenette A. Bennett
Correspondent
Cenorin, LLC
6324 South 199th Place
Suite 107
Kent,  WA  98032
Correspondent Contact Jenette A. Bennett
Regulation Number880.6991
Classification Product Code
LDS  
Date Received12/12/2018
Decision Date 09/09/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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