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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 K133367
Device Name ORTHOVIS PREOPERATIVE PLAN
Applicant
Custom Orthopaedic Solutions
10000 Cedar Ave.
Cleveland,  OH  44106
Applicant Contact JUSTIN BAKER
Correspondent
Custom Orthopaedic Solutions
10000 Cedar Ave.
Cleveland,  OH  44106
Correspondent Contact JUSTIN BAKER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/01/2013
Decision Date 12/20/2013
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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