FDA 510(k) Application Details - K150627

Device Classification Name	Infant Heel Warmer (Chemical Heat Pack)   More FDA Info for this Device
510(K) Number	K150627
Device Name	Infant Heel Warmer (Chemical Heat Pack)
Applicant	RAPID AID CORP. 4120 A SLADEVIEW CRESENT MISSISSAUGA L5L 5Z3 CA Other 510(k) Applications for this Company
Contact	Rose Ren 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	03/11/2015
Decision Date	05/27/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review