FDA 510(k) Application Details - K102556

Device Classification Name System, Image Processing, Radiological

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510(K) Number K102556
Device Name System, Image Processing, Radiological
Applicant MATAKINA TECHNOLOGY LIMITED
Level 6,
86 Victoria Street
Wellington 6142 NZ
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Contact SHEILA W PICKERING
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 09/07/2010
Decision Date 10/07/2010
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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