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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 K160584
Device Name Surgical Navigation Advanced Platform (SNAP)
Applicant
SURGICAL THEATER, LLC
781 BETA DR.
MAYFIELD VILLAGE,  OH  44143
Applicant Contact Kevin Murrock
Correspondent
SURGICAL THEATER, LLC
781 BETA DR.
MAYFIELD VILLAGE,  OH  44143
Correspondent Contact Kevin Murrock
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/01/2016
Decision Date 06/28/2016
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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