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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 K113344
Device Name STEREOS WORKSTATION
Applicant
Eos Imaging
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact JOHN J SMITH
Correspondent
Eos Imaging
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact JOHN J SMITH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/14/2011
Decision Date 11/16/2012
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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