FDA 510(k) Application Details - K153713

Device Classification Name	Warmer, Irrigation Solution   More FDA Info for this Device
510(K) Number	K153713
Device Name	Warmer, Irrigation Solution
Applicant	GETINGE SOURCING, LLC 1777 EAST HENRIETTA ROAD ROCHESTER, NY 14623 US Other 510(k) Applications for this Company
Contact	BARB SMITH Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LHC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/2015
Decision Date	06/07/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review