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510(k) Data Aggregation

K Number

Device Name

ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)

Manufacturer

ThermaSolutions, LLC

Date Cleared

2025-05-05

(445 days)

Product Code

MLW

Regulation Number

876.5630

Why did this record match?

Applicant Name (Manufacturer) :

ThermaSolutions, LLC

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

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