FDA 510(k) Application Details - K994186

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K994186
Device Name	Pump, Infusion, Insulin
Applicant	DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE FT. MEYERS, FL 33912 US Other 510(k) Applications for this Company
Contact	Lee Leichter 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	12/10/1999
Decision Date	12/30/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review