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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, test, blood glucose, over the counter
510(k) Number K162203
Device Name POGO Automatic Blood Glucose Monitoring System
Applicant
Intuity Medical, Inc.
526 Almanor Avenue
sunnyvale,  CA  94085
Applicant Contact robb hesley
Correspondent
Domecus Consulting Services LLC
1171 Barroilhet Drive
hillsborough,  CA  94010
Correspondent Contact cindy domecus
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received08/05/2016
Decision Date 04/06/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT02333864
Reviewed by Third Party No
Combination Product No
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