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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name light based over-the-counter hair removal
510(k) Number K190354
Device Name BRAUN Silk.expert Pro 5
Applicant
CyDen Limited
Block A, Bay Studios Business Park,
Fabian Way
Swansea,  GB SA1 8QB
Applicant Contact Adam Stephens
Correspondent
CyDen Limited
Block A, Bay Studios Business Park,
Fabian Way
Swansea,  GB SA1 8QB
Correspondent Contact Adam Stephens
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
GEX  
Date Received02/15/2019
Decision Date 03/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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