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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 K191202
Device Name CAPENERGY - C100, C200, C300, C400, C50
Applicant
Capenergy Medical SL
Avinguda Mare de Deu de Montserrat, 41
Sant Joan Despi, Barcelona,  ES 08970
Applicant Contact Pilar Sanchez
Correspondent
Capenergy Medical SL
Avinguda Mare de Deu de Montserrat, 41
Sant Joan Despi, Barcelona,  ES 08970
Correspondent Contact Pilar Sanchez
Regulation Number878.4400
Classification Product Code
PBX  
Date Received05/06/2019
Decision Date 02/11/2020
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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