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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 K060876
Device Name ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
Applicant
Disetronic Medical Systems AG
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact Scott Thiel
Correspondent
Disetronic Medical Systems AG
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact Scott Thiel
Regulation Number880.5725
Classification Product Code
LZG  
Date Received03/31/2006
Decision Date 06/15/2006
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
Recalls CDRH Recalls
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