FDA 510(k) Application Details - K972202

Device Classification Name Electroencephalograph

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510(K) Number K972202
Device Name Electroencephalograph
Applicant GRASS-TELEFACTOR PRODUCT GROUP
1094 NEW DEHAVEN AVE.
WEST CONSHOHOCKEN, PA 19428 US
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Contact JAMES S BRYAN
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Regulation Number 882.1400

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Classification Product Code GWQ
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Date Received 06/11/1997
Decision Date 07/23/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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