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FDA 510(k) Application Details - K062641
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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510(K) Number
K062641
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
AVAZZIA, INC.
13154 COIT RD., STE. 200
DALLAS, TX 75240 US
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CATHERINE TONE
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Regulation Number
882.5890
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Classification Product Code
GZJ
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Date Received
09/06/2006
Decision Date
04/30/2007
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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