FDA 510(k) Application Details - K060876

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K060876
Device Name	Pump, Infusion, Insulin
Applicant	DISETRONIC MEDICAL SYSTEMS AG 9115 Hague Road Indianapolis, IN 46250-0457 US Other 510(k) Applications for this Company
Contact	Scott Thiel Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	LZG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2006
Decision Date	06/15/2006
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