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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 K171450
Device Name Glooko Mobile Insulin Dosing System
Applicant
Glooko, Inc.
899 W. Evelyn Ave.
Mountain View,  CA  94041
Applicant Contact Tejasvi Pasi
Correspondent
Glooko, Inc.
899 W. Evelyn Ave.
Mountain View,  CA  94041
Correspondent Contact Tejasvi Pasi
Regulation Number868.1890
Classification Product Code
NDC  
Date Received05/17/2017
Decision Date 02/02/2018
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
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