FDA 510(k) Application Details - K971708

Device Classification Name Device, Biofeedback

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510(K) Number K971708
Device Name Device, Biofeedback
Applicant J & J ENGINEERING, INC.
55 NORTHERN BLVD., SUITE 410
GREAT NECK, NY 11021 US
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Contact ANAND AKERKAR
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Regulation Number 882.5050

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Classification Product Code HCC
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Date Received 05/08/1997
Decision Date 02/18/1998
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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