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FDA 510(k) Application Details - K122711
Device Classification Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
More FDA Info for this Device
510(K) Number
K122711
Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant
NUSKIN
ONE METRO CENTER 700
12TH STREET, SUITE 900
WASHINGTON, DC 20005 US
Other 510(k) Applications for this Company
Contact
PAUL RUBIN
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
NFO
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More FDA Info for this Product Code
Date Received
09/04/2012
Decision Date
09/17/2013
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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