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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Peritoneal Dialysate
510(k) Number K131583
Device Name THERMOCHEM HT-2000
Applicant
Thermasolutions, Inc.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Applicant Contact M.W. ANDY ANDERSON PH.D. RAC
Correspondent
Thermasolutions, Inc.
5353 Wayzata Blvd. Suite 505
Minneapolis,  MN  55416
Correspondent Contact M.W. ANDY ANDERSON PH.D. RAC
Regulation Number876.5630
Classification Product Code
MLW  
Date Received05/31/2013
Decision Date 10/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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