FDA 510(k) Application Details - K112547

Device Classification Name	Pack, Hot Or Cold, Disposable   More FDA Info for this Device
510(K) Number	K112547
Device Name	Pack, Hot Or Cold, Disposable
Applicant	DENOVO PROUCTS LLC 17051 ALICO COMMERCE CT. #3 FT. MYERS, FL 33967 US Other 510(k) Applications for this Company
Contact	DALE WALTERS Other 510(k) Applications for this Contact
Regulation Number	890.5710   More FDA Info for this Regulation Number
Classification Product Code	IMD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/01/2011
Decision Date	03/06/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review