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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 K111353
Device Name ACCU-CHECK COMBO SYSTEM
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Applicant Contact Scott Thiel
Correspondent
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS,  IN  46250 -0416
Correspondent Contact Scott Thiel
Regulation Number880.5725
Classification Product Code
LZG  
Subsequent Product Codes
NBW   NDC  
Date Received05/16/2011
Decision Date 07/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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