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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K170540
Device Name DM-Density
Applicant
Densitas, Inc.
1344 Summer Street, Suite 311.2
Halifax,  CA B3H 0A8
Applicant Contact Mo Abdolell
Correspondent
Emergo Group, Inc.
2500 Bee Cave Road, Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Ken Pilgrim
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/23/2017
Decision Date 02/23/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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