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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
Original Applicant
ROCHE DIAGNOSTICS
9115 hague road
indianapolis,  IN  46250 0416
Original 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 (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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