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Thermasolutions, LLC
FDA Regulatory Profile
Summary
Total Recalls
0
510(k) Clearances
3
Inspections
3
Compliance Actions
1
Recent 510(k) Clearances
K-Number
Device
Date
K240447
ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)
May 5, 2025
K222575
HurriChem Device Kit
December 6, 2022
K131583
THERMOCHEM HT-2000
October 3, 2013