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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 K173574
Device Name DenSeeMammo
Applicant
Statlife
39 Rue Camille Desmoulins
Villejuif,  FR 94800
Applicant Contact Stephane Ragusa
Correspondent
Statlife
50 Milk St., 16th Floor
Boston,  MA  02109
Correspondent Contact Valérie Hélin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/20/2017
Decision Date 06/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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