FDA 510(k) Application Details - K133800

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K133800
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	HGI INDUSTIRES 2055 HIGH RIDGE ROAD BOYNTON BEACH, FL 33426 US Other 510(k) Applications for this Company
Contact	CONNIE ARAPS, PHD Other 510(k) Applications for this Contact
Regulation Number	880.6500   More FDA Info for this Regulation Number
Classification Product Code	FRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2013
Decision Date	12/19/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review