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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 K050312
Device Name AMIGO INSULIN PUMP
Applicant
Nipro Diabetes Systems, Inc.
3361 Enterprise Way
Miramar,  FL  33025
Applicant Contact CLARENCE ODOM
Correspondent
Nipro Diabetes Systems, Inc.
3361 Enterprise Way
Miramar,  FL  33025
Correspondent Contact CLARENCE ODOM
Regulation Number880.5725
Classification Product Code
LZG  
Date Received02/08/2005
Decision Date 05/09/2005
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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