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FDA 510(k) Application Details - K162479
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K162479
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
NO. 3 BUILDING XILIBAIMANG XUSHENG INDUSTRIAL ESTATE
NANSHAN
SHENZHEN 518108 CN
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Contact
TRUMAN SHEN
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
NUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/06/2016
Decision Date
02/08/2017
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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