FDA 510(k) Application Details - K063839

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K063839
Device Name Accelerator, Linear, Medical
Applicant C-RAD POSITIONING AB
KUNGSANGSVAGEN 29
UPPSALA 75323 SE
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Contact BENGT ERIC ROSTH
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 12/26/2006
Decision Date 02/08/2007
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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