FDA 510(k) Application Details - K965006

Device Classification Name Device, Biofeedback

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510(K) Number K965006
Device Name Device, Biofeedback
Applicant STOELTING CO.
620 WHEAT LN.
WOOD DALE, IL 60191 US
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Contact JOHN ZIOBRO
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Regulation Number 882.5050

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Classification Product Code HCC
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Date Received 12/16/1996
Decision Date 02/05/1997
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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