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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 K071613
Device Name AMIGO INSULIN PUMP
Applicant
Nipro Diabetes Systems, Inc.
3361 Enterprise Pkwy.
Miramar,  FL  33025
Applicant Contact HARRY RUSSELL
Correspondent
Nipro Diabetes Systems, Inc.
3361 Enterprise Pkwy.
Miramar,  FL  33025
Correspondent Contact HARRY RUSSELL
Regulation Number880.5725
Classification Product Code
LZG  
Date Received06/13/2007
Decision Date 12/14/2007
Decision Substantially Equivalent (SESE)
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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