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FDA 510(k) Application Details - K052182
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
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510(K) Number
K052182
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
SHIAN JIA MEEI ENTERPRISE CO., LTD.
3892 SOUTH AMERICA WEST TRAIL
FLAGSTAFF, AZ 86001 US
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Contact
JENNIFER REICH
Other 510(k) Applications for this Contact
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
08/10/2005
Decision Date
11/04/2005
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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