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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 K201465
Device Name SuRgical Planner (SRP) BrainStorm
Applicant
Surgical Theater, Inc.
781 Beta Drive
Mayfield Village,  OH  44143
Applicant Contact Kevin Murrock
Correspondent
Surgical Theater, Inc.
781 Beta Drive
Mayfield Village,  OH  44143
Correspondent Contact Kevin Murrock
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/02/2020
Decision Date 07/17/2020
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
Recalls CDRH Recalls
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