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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K230412
Device Name Symmed Elite Aesthetic
Applicant
Termosalud
Calle Ataulfo Friera Tarfe, 8-33211
Gijon,  ES
Applicant Contact Cristina Cifuentes Pantoja
Correspondent
Hoy and Associates Regulatory Consulting
1830 Bonnie Way
Sacramento,  CA  95825
Correspondent Contact Aubrey Thompson
Regulation Number878.4400
Classification Product Code
PBX  
Date Received02/15/2023
Decision Date 04/13/2023
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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