FDA 510(k) Application Details - K063579

Device Classification Name System, Image Processing, Radiological

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510(K) Number K063579
Device Name System, Image Processing, Radiological
Applicant CHI LIN TECHNOLOGY CO., LTD.
3F, # 86, SEC 1 WUNHUA 1ST RD.
LINKUO, TAIPEI HSIEN 244 TW
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Contact JUDY LIN
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/30/2006
Decision Date 12/14/2006
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 Y
Expedited Review



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