FDA 510(k) Application Details - K083417

Device Classification Name	Warmer, Irrigation Solution   More FDA Info for this Device
510(K) Number	K083417
Device Name	Warmer, Irrigation Solution
Applicant	C CHANGE SURGICAL LLC 101 NORTH CHESTNUT STREET SUITE 301 WINSTON-SALEM, NC 27101 US Other 510(k) Applications for this Company
Contact	PATRICK KAMMER 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	11/18/2008
Decision Date	01/13/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review