FDA 510(k) Application Details - K060933

Device Classification Name	Pump, Infusion, Elastomeric   More FDA Info for this Device
510(K) Number	K060933
Device Name	Pump, Infusion, Elastomeric
Applicant	APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	WHITNEY WILLIAMS Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2006
Decision Date	05/09/2006
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	Y
Expedited Review