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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calculator, drug dose
510(k) Number K171230
Device Name My Dose Coach
Applicant
Sanofi
640 Memorial Drive
cambridge,  MA  02142
Applicant Contact robert ezzell
Correspondent
Sanofi
640 Memorial Drive
cambridge,  MA  02142
Correspondent Contact robert ezzell
Regulation Number868.1890
Classification Product Code
NDC  
Date Received04/27/2017
Decision Date 05/26/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
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