FDA 510(k) Application Details - K171234

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K171234
Device Name	System, Thermal Regulating
Applicant	The Surgical Company International BV (as The 37Company) Beeldschermweg 6F Amersfoort 3821 AH NL Other 510(k) Applications for this Company
Contact	Kees van Hassel Other 510(k) Applications for this Contact
Regulation Number	870.5900   More FDA Info for this Regulation Number
Classification Product Code	DWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2017
Decision Date	05/26/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review