FDA 510(k) Application Details - K183444

Device Classification Name	Device, Pasteurization, Hot Water   More FDA Info for this Device
510(K) Number	K183444
Device Name	Device, Pasteurization, Hot Water
Applicant	Cenorin, LLC 6324 South 199th Place Suite 107 Kent, WA 98032 US Other 510(k) Applications for this Company
Contact	Jenette A. Bennett Other 510(k) Applications for this Contact
Regulation Number	880.6991   More FDA Info for this Regulation Number
Classification Product Code	LDS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/12/2018
Decision Date	09/09/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review