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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 K161433
Device Name Insulia Diabetes Management Companion
Applicant
VOLUNTIS S.A.
58, AVENUE DE WAGRAM
Paris,  FR 75017
Applicant Contact RAFFI KRIKORIAN
Correspondent
VOLUNTIS S.A.
2, RUE DES BOURETS
Suresnes,  FR 92150
Correspondent Contact RAFFI KRIKORIAN
Regulation Number868.1890
Classification Product Code
NDC  
Date Received05/24/2016
Decision Date 11/09/2016
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
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