FDA 510(k) Application Details - K974682

Device Classification Name	Cleaner, Air, Medical Recirculating   More FDA Info for this Device
510(K) Number	K974682
Device Name	Cleaner, Air, Medical Recirculating
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	880.5045   More FDA Info for this Regulation Number
Classification Product Code	FRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/1997
Decision Date	01/23/1998
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