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FDA 510(k) Application Details - K181008
Device Classification Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
More FDA Info for this Device
510(K) Number
K181008
Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Applicant
Carol Cole Company dba NuFACE
1325 Sycamore Ave. Suite A
Vista, CA 92081 US
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Contact
Donald Ellis
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
NFO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/17/2018
Decision Date
10/11/2018
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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