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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 K240447
Device Name ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
Applicant
Thermasolutions, LLC
1889 Buerkle Rd.
White Bear Lake,  MN  55110
Applicant Contact Rhea Johny
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Jessica Czamanski
Regulation Number876.5630
Classification Product Code
MLW  
Date Received02/15/2024
Decision Date 05/05/2025
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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