FDA 510(k) Application Details - K163295

Device Classification Name	Pack, Hot Or Cold, Disposable   More FDA Info for this Device
510(K) Number	K163295
Device Name	Pack, Hot Or Cold, Disposable
Applicant	RAPID AID CORP. 4120 A SLADEVIEW CRESENT MISSISSAUGA L5L 5Z3 CA Other 510(k) Applications for this Company
Contact	Laureta Prifti 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	11/22/2016
Decision Date	07/24/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review