FDA 510(k) Application Details - K972107

Device Classification Name	Pump, Infusion, Insulin   More FDA Info for this Device
510(K) Number	K972107
Device Name	Pump, Infusion, Insulin
Applicant	MEDTRONIC MINIMED 12744 SAN FERNANDO RD. SYLMAR, CA 91342 US Other 510(k) Applications for this Company
Contact	DON SELVEY 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	06/05/1997
Decision Date	08/15/1997
Decision	ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review