FDA 510(k) Application Details - K972122

Device Classification Name Electrode, Cutaneous

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510(K) Number K972122
Device Name Electrode, Cutaneous
Applicant REST TECHNOLOGIES, INC.
827 20TH ST.
SANTA MONICA, CA 90403 US
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Contact RONALD LUICH
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 06/05/1997
Decision Date 08/29/1997
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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