FDA 510(k), K201906, Trinity ELE Plus and Trinity ELE Plus Pro
FDA 510(k), K201906, Trinity ELE Plus and Trinity ELE Plus Pro
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510(K) Number: K201906
Device Name: Trinity ELE Plus and Trinity ELE Plus Pro
Manufacturer: Carol Cole Company dba NuFACE
Device Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation Number: 882.5890
Classification Product Code: NFO
Date Received: 07/09/2020
Decision Date: 02/24/2021
Regulation Medical Specialty: Neurology
Device Name: Trinity ELE Plus and Trinity ELE Plus Pro
Manufacturer: Carol Cole Company dba NuFACE
Device Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation Number: 882.5890
Classification Product Code: NFO
Date Received: 07/09/2020
Decision Date: 02/24/2021
Regulation Medical Specialty: Neurology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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