FDA 510(k) Application Details - K961718

Device Classification Name Device, Biofeedback

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510(K) Number K961718
Device Name Device, Biofeedback
Applicant DISCOVERY ENGINEERING INTL., INC.
3115 WESTWOOD DR.
TOPEKA, KS 66614-2741 US
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Contact REX HARTZELL
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Regulation Number 882.5050

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Classification Product Code HCC
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Date Received 05/02/1996
Decision Date 08/27/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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