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FDA 510(k) Application Details - K121578
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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510(K) Number
K121578
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
BIOELECTRIC RESEARCH CORPORATION
112 N. CURRY STREET
CARSON CITY, NV 89703 US
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Contact
STEVEN KAYE
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Regulation Number
882.5890
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Classification Product Code
GZJ
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More FDA Info for this Product Code
Date Received
05/30/2012
Decision Date
07/31/2012
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
Y
Expedited Review
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