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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 K123023
Device Name SURGERY REHEARSAL PLATFORM
Applicant
Surgical Theater, LLC
151 Innovation Dr.
Elyria,  OH  44141
Applicant Contact MORDECHAI AVISAR
Correspondent
Surgical Theater, LLC
151 Innovation Dr.
Elyria,  OH  44141
Correspondent Contact MORDECHAI AVISAR
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/28/2012
Decision Date 02/08/2013
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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