FDA 510(k) Application Details - K972064

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K972064
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	BIOLOGICAL CONTROLS, INC. ONE INDUSTRIAL WAY WEST BUILDING E, UNIT M EATONTOWN, NJ 07724 US Other 510(k) Applications for this Company
Contact	GARY D MESSINA 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	06/03/1997
Decision Date	12/01/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review