FDA 510(k) Application Details - K050993

Device Classification Name System, Image Processing, Radiological

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510(K) Number K050993
Device Name System, Image Processing, Radiological
Applicant MEDICAL MEASUREMENT SYSTEMS,B.V.
COLOSSEUM 25
ENSCHEDE 7521 PV NL
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Contact KARIN OGINK-SOMHORST
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 04/19/2005
Decision Date 05/26/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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