FDA 510(k) Application Details - K132048

Device Classification Name	System, Thermal Regulating   More FDA Info for this Device
510(K) Number	K132048
Device Name	System, Thermal Regulating
Applicant	MOLNLYCKE HEALTH CARE US, LLC 5550 PEACHTREE PARKWAY SUITE 500 NORCROSS, GA 30092 US Other 510(k) Applications for this Company
Contact	CURTIS D TRUESDALE 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	07/02/2013
Decision Date	11/06/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review