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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion, Insulin
510(k) Number K972107
Device Name MINIMED INFUSION PUMP, MODEL 507C
Applicant
Medtronic Minimed
12744 San Fernando Rd.
Sylmar,  CA  91342
Applicant Contact DON SELVEY
Correspondent
Medtronic Minimed
12744 San Fernando Rd.
Sylmar,  CA  91342
Correspondent Contact DON SELVEY
Regulation Number880.5725
Classification Product Code
LZG  
Date Received06/05/1997
Decision Date 08/15/1997
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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