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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 K163099
Device Name My Dose Coach
Applicant
Sanofi, Inc.
640 Memorial Dr.
Cambridge,  MA  02139
Applicant Contact Robert Ezzell
Correspondent
Sanofi, Inc.
640 Memorial Dr.
Cambridge,  MA  02139
Correspondent Contact Robert Ezzell
Regulation Number868.1890
Classification Product Code
NDC  
Date Received11/07/2016
Decision Date 03/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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