FDA 510(k) Application Details - K993654

Device Classification Name Device, Biofeedback

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510(K) Number K993654
Device Name Device, Biofeedback
Applicant NEUROCYBERNETICS
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 882.5050

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Classification Product Code HCC
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Date Received 10/29/1999
Decision Date 01/27/2000
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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