FDA 510(k) Application Details - K961050

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

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510(K) Number K961050
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant MAVEN LABS, INC.
1233 20TH ST. N.W.
SUITE 700
WASHINGTON, DC 20036 US
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Contact DANIEL J MANELLI
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 02/08/1996
Decision Date 08/01/1997
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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