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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical Coagulation For Aesthetic
510(k) Number K210077
Device Name MED RF 4000
Applicant
F Care Systems USA, LLC
11098 Biscayne Blvd. Suite 301
Miami,  FL  33161
Applicant Contact Patrick Danciu
Correspondent
F Care Systems USA, LLC
11098 Biscayne Blvd. Suite 301
Miami,  FL  33161
Correspondent Contact Patrick Danciu
Regulation Number878.4400
Classification Product Code
ONQ  
Date Received01/12/2021
Decision Date 12/17/2021
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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