FDA 510(k) Application Details - K984589

Device Classification Name	Unit, Neonatal Phototherapy   More FDA Info for this Device
510(K) Number	K984589
Device Name	Unit, Neonatal Phototherapy
Applicant	MEDELA, INC. 4610 PRIME PKWY. P.O. BOX 660 MCHENRY, IL 60050-7005 US Other 510(k) Applications for this Company
Contact	STEPHEN D SMITH Other 510(k) Applications for this Contact
Regulation Number	880.5700   More FDA Info for this Regulation Number
Classification Product Code	LBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/1998
Decision Date	04/20/1999
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