FDA 510(k) Application Details - K940954

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K940954
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant THE SYNAPTIC CORP.
3177 SOUTH PARKER RD.
AURORA, CO 80014 US
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Contact MARK K SHANER
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 03/01/1994
Decision Date 06/20/1997
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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