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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 K041318
Device Name MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
Applicant
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325 -1219
Applicant Contact MARK J FAILLACE
Correspondent
Medtronic Minimed
18000 Devonshire St.
Northridge,  CA  91325 -1219
Correspondent Contact MARK J FAILLACE
Regulation Number880.5725
Classification Product Code
LZG  
Date Received05/18/2004
Decision Date 07/19/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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