FDA 510(k) Application Details - K971400

Device Classification Name Device, Biofeedback

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510(K) Number K971400
Device Name Device, Biofeedback
Applicant ENRICHING YOUR LIFE
6339 KELLY DR.
GRANBURY, TX 76048 US
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Contact MARY LOU WILSON
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Regulation Number 882.5050

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Classification Product Code HCC
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Date Received 04/15/1997
Decision Date 04/14/1998
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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