FDA 510(k) Application Details - K101503

Device Classification Name Accelerator, Linear, Medical

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510(K) Number K101503
Device Name Accelerator, Linear, Medical
Applicant MATH RESOLUTIONS, LLC.
5975 GALES LN.
COLUMBIA, MD 21045 US
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Contact WENDEL D RENNER
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Regulation Number 892.5050

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Classification Product Code IYE
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Date Received 06/01/2010
Decision Date 08/04/2010
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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