FDA 510(k) Application Details - K980745

Device Classification Name	Purifier, Air, Ultraviolet, Medical   More FDA Info for this Device
510(K) Number	K980745
Device Name	Purifier, Air, Ultraviolet, Medical
Applicant	MONAGAN ENT., INC. 14247 RIDGE RD. ALBION, NY 14411 US Other 510(k) Applications for this Company
Contact	GERALD C MONAGAN 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	02/26/1998
Decision Date	04/02/1999
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