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510(k) K201680

NuFACE Mini Plus by Carole Cole Company — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2021
Date Received
June 22, 2020
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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