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FDA 510(k) Application Details - K122410
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K122410
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
MEDIRUNE CO, LTD
821 SAMIL PLAZA
837-26 YEUKSAM-DONG
GANGNAM-GU 135-768 KR
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Contact
YANG HO DONG
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
NUH
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More FDA Info for this Product Code
Date Received
08/08/2012
Decision Date
11/12/2013
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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