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FDA 510(k) Application Details - K152199
Device Classification Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
More FDA Info for this Device
510(K) Number
K152199
Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant
TROPHY SKIN, INC.
4372 KENMARE TRAIL
FRISCO, TX 75034 US
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Contact
IMRAN KARIM
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Regulation Number
882.5890
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Classification Product Code
NFO
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More FDA Info for this Product Code
Date Received
08/06/2015
Decision Date
03/23/2016
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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