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FDA 510(k) Application Details - K200694
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
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510(K) Number
K200694
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
TensCare Ltd.
9 Blenheim Road, Longmead Business Park
Epsom KT19 9BE GB
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Contact
Andrew Brown
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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
03/17/2020
Decision Date
06/04/2021
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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