FDA 510(k) Application Details - K062143

Device Classification Name	Holder, Infant Position   More FDA Info for this Device
510(K) Number	K062143
Device Name	Holder, Infant Position
Applicant	ALFRED E MANN INST. FOR BIOMEDICAL ENGINEERING 1042 DOWNEY WAY, DRB 101 LOS ANGELES, CA 90089-1112 US Other 510(k) Applications for this Company
Contact	ARMAN H NADERSHAHI Other 510(k) Applications for this Contact
Regulation Number	880.5680   More FDA Info for this Regulation Number
Classification Product Code	FRP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2006
Decision Date	10/24/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review