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FDA 510(k) Application Details - K230659
Device Classification Name
More FDA Info for this Device
510(K) Number
K230659
Device Name
Zionic Aesthetic
Applicant
TermoSalud
Calle Ataulfo Friera Tarfe, 8-33211
Gijon ES
Other 510(k) Applications for this Company
Contact
Cristina Cifuentes Pantoja
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PBX
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More FDA Info for this Product Code
Date Received
03/09/2023
Decision Date
06/08/2023
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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