FDA 510(k) Application Details - K032996

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K032996
Device Name Accelerator, Linear, Medical
Applicant ELEKTA ONCOLOGY SYSTEMS, LTD.
4775 PEACHTREE INDUSTRIAL BLVD
BLDG 300, SUITE 300
NORCROSS, GA 30092 US
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Contact PETER STEGAGNO
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 09/25/2003
Decision Date 10/23/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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