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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 K171534
Device Name SurgicalPreview
Applicant
Endo Vantage, LLC
1475 N. Scottsdale Rd., Suite 200
Scottsdale,  AZ  85257
Applicant Contact Robert S. Green
Correspondent
CardioMed Device Consultants, LLC
1783 Forest Dr.
Suite 254
Annapolis,  MD  21401
Correspondent Contact H. Semih Oktay
Regulation Number892.2050
Classification Product Code
PZO  
Date Received05/25/2017
Decision Date 11/08/2017
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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