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FDA 510(k) Application Details - K192138
Device Classification Name
More FDA Info for this Device
510(K) Number
K192138
Device Name
Rejuvapen NXT
Applicant
Refine USA LLC
340 3rd Avenue South Suite C
Jacksonville Beach, FL 32250 US
Other 510(k) Applications for this Company
Contact
Brian Smith
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QAI
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More FDA Info for this Product Code
Date Received
08/08/2019
Decision Date
04/09/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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