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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 K100236
Device Name STAIR SYSTEMS PACS & DICOM VIEWER
Applicant
STAIR SYSTEMS, INC.
747 cedard hill drive
allentown,  PA  18109
Applicant Contact james w monroe
Correspondent
STAIR SYSTEMS, INC.
747 cedard hill drive
allentown,  PA  18109
Correspondent Contact james w monroe
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/26/2010
Decision Date 03/29/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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