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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 K190764
Device Name SurgicalAR
Applicant
MEDIVIS, Inc.
20 Jay Street Suite 312
Brooklyn,  NY  11201
Applicant Contact Amy Lynn
Correspondent
MEDIVIS, Inc.
20 Jay Street Suite 312
Brooklyn,  NY  11201
Correspondent Contact Amy Lynn
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/25/2019
Decision Date 05/13/2019
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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