FDA 510(k) Application Details - K110772

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K110772
Device Name Accelerator, Linear, Medical
Applicant CARBON MEDICAL TECHNOLOGIES, INC.
1290 HAMMOND RD.
ST. PAUL, MN 55110-5867 US
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Contact ANDREW J ADAMS
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 03/21/2011
Decision Date 04/28/2011
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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