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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software For Visualization Of Vascular Anatomy And Intravascular Devices
510(k) Number K190049
Device Name Sim&Size
Applicant
Sim&Cure
1682 Rue De La Valsiere
Grabels,  FR 34790
Applicant Contact Krishna Mahadea
Correspondent
Medicept, LLC
22 Nichols St.
#2
Salem,  MA  01970
Correspondent Contact Scott Blood
Regulation Number892.2050
Classification Product Code
PZO  
Date Received01/10/2019
Decision Date 09/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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