FDA 510(k) Application Details - K070611

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K070611
Device Name Accelerator, Linear, Medical
Applicant NOMOS CORP.
200 WEST KENSINGER DR.
SUITE 100
CRANBERRY TOWNSHIP, PA 16066 US
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Contact MARITA BRUST
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 03/05/2007
Decision Date 07/11/2007
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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