FDA 510(k) Application Details - K092424

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K092424
Device Name Accelerator, Linear, Medical
Applicant P-CURE LTD
4A HAGAVISH ST
NETANYA, HASHARON 42101 IL
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Contact MICHAEL MARASH
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 08/07/2009
Decision Date 03/05/2010
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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