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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Microneedle Device
510(k) Number K192138
Device Name Rejuvapen NXT
Applicant
Refine USA, LLC
340 3rd Ave. S. Suite C
Jacksonville Beach,  FL  32250
Applicant Contact Brian Smith
Correspondent
Technireg, Inc.
19404 Pine Valley Dr.
Odessa,  FL  33556 -3955
Correspondent Contact Wayne Glover
Regulation Number878.4430
Classification Product Code
QAI  
Date Received08/08/2019
Decision Date 04/09/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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