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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
510(k) Number K912458
Device Name MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
Applicant
Medtronic Minimed
12744 San Fernando Rd.
Sylmar,  CA  91342
Applicant Contact CYNTHIA L LUCHETTI
Correspondent
Medtronic Minimed
12744 San Fernando Rd.
Sylmar,  CA  91342
Correspondent Contact CYNTHIA L LUCHETTI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/24/1991
Decision Date 06/24/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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