FDA 510(k), K201782, NuFace Trinity Plus Device
FDA 510(k), K201782, NuFace Trinity Plus Device
510(K) Number: K201782
Device Name: NuFace Trinity Plus Device
Manufacturer: Carol Cole Company dba NuFACE
Device Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation Number: 882.5890
Classification Product Code: NFO
Date Received: 06/30/2020
Decision Date: 01/22/2021
Regulation Medical Specialty: Neurology
Total pages: 739
Fully redacted pages: 542
Content pages: 197
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