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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
HOPKINTON,  MA  01748
Applicant Contact DEBBIE IAMPIETRO
Correspondent
ETRAUMA.COM CORP.
7 TIFFANY TRAIL
HOPKINTON,  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
Recalls CDRH Recalls
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