FDA 510(k) Application Details - K240447

Device Classification Name	Warmer, Peritoneal Dialysate   More FDA Info for this Device
510(K) Number	K240447
Device Name	Warmer, Peritoneal Dialysate
Applicant	ThermaSolutions, LLC 1889 Buerkle Road White Bear Lake, MN 55110 US Other 510(k) Applications for this Company
Contact	Rhea Johny Other 510(k) Applications for this Contact
Regulation Number	876.5630   More FDA Info for this Regulation Number
Classification Product Code	MLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2024
Decision Date	05/05/2025
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review