FDA 510(k) Application Details - K100236

Device Classification Name System, Image Processing, Radiological

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510(K) Number K100236
Device Name System, Image Processing, Radiological
Applicant STAIR SYSTEMS, INC.
747 CEDARD HILL DRIVE
ALLENTOWN, PA 18109 US
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Contact JAMES W MONROE
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 01/26/2010
Decision Date 03/29/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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