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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 K172177
Device Name Insulia Diabetes Management Companion
Applicant
Voluntis Sa.
22 Quai Gallieni
Suresnes,  FR 92150
Applicant Contact Kevin Howard
Correspondent
Voluntis Sa.
22 Quai Gallieni
Suresnes,  FR 92150
Correspondent Contact Kevin Howard
Regulation Number868.1890
Classification Product Code
NDC  
Date Received07/19/2017
Decision Date 11/07/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
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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