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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 K073714
Device Name TRAUMACAD VERSION 2.0
Applicant
Orthocrat, Ltd.
291 Hillside Ave.
Somerset,  MA  02726
Applicant Contact GEORGE J HATTUB
Correspondent
Orthocrat, Ltd.
291 Hillside Ave.
Somerset,  MA  02726
Correspondent Contact GEORGE J HATTUB
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/31/2007
Decision Date 03/19/2008
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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