THERMASOLUTIONS LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30056997843005699784THERMASOLUTIONS LLC.1N2026-01-011889 Buerkle Rd White Bear Lake MN US 55110

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
661871900037050K993330THERMOCHEM-HT SYSTEMMLW1999-12-30
661871466348027K240447ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000)MLW2025-05-05
661871372520900K222575HurriChem Device KitGCJ2022-12-06
661871284381970K131583THERMOCHEM HT-2000MLW2013-10-03
661871816742111K101244SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBEFLL2010-11-18
661871650881127

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MLW32025-05-05
GCJ12022-12-06
FLL12010-11-18