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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 Dr.
Allentown,  PA  18109
Applicant Contact JAMES W MONROE
Correspondent
Stair Systems, Inc.
747 Cedard Hill Dr.
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
Predetermined Change
Control Plan Authorized		 No
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