FDA 510(k) Application Details - K103549

Device Classification Name	Infant Heel Warmer (Chemical Heat Pack)   More FDA Info for this Device
510(K) Number	K103549
Device Name	Infant Heel Warmer (Chemical Heat Pack)
Applicant	DENOVO PRODUCTS LLC 17051 Alico Commerce Court Unit 3 Fort 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	MPO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/2010
Decision Date	04/08/2011
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