FDA 510(k) Application Details - K062284

Device Classification Name

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510(K) Number K062284
Device Name CES ULTRA
Applicant NEURO-FITNESS LLC
P.O. BOX 1031
SNOQUALMIE, WA 98065 US
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Contact MICHAEL STEVENS
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Regulation Number

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Classification Product Code QJQ
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Date Received 08/07/2006
Decision Date 04/05/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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