FDA 510(k) Application Details - K052711

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

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510(K) Number K052711
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant EMJOI, INC.
2943 OAK LAKE BLVD.
MIDLOTHIAN, VA 23112 US
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Contact MIKE JUDGE
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 09/29/2005
Decision Date 06/23/2006
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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