FDA 510(k) Application Details - K010616

Device Classification Name	Cleaner, Air, Medical Recirculating   More FDA Info for this Device
510(K) Number	K010616
Device Name	Cleaner, Air, Medical Recirculating
Applicant	HMI INDUSTRIES, INC. 13325 DARICE PKWY. STRONGVILLE, OH 44149 US Other 510(k) Applications for this Company
Contact	JACQUELINE PERCELL 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	03/01/2001
Decision Date	03/28/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review