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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 K033825
Device Name ORTHOPACS
Applicant
Etrauma.Com Corp.
7 Tiffany Trail
Hopkonton,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
Etrauma.Com Corp.
7 Tiffany Trail
Hopkonton,  MA  01748
Correspondent Contact DEBBIE IAMPIETRO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/10/2003
Decision Date 02/02/2004
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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