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FDA 510(k) Application Details - K090042
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K090042
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
NEWMARK, INC.
919 EIGHTEENTH STREET NW
SUITE 600
WASHINGTON, DC 20006 US
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Contact
DEBORAH LIVORNESE
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
NUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2009
Decision Date
05/06/2009
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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