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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 K181893
Device Name T-PLUS
Applicant
Wintecare SA
Via Livio 12
Chiasso,  CH 6830
Applicant Contact Claudio Freti
Correspondent
Wintecare SA
Via Livio 12
Chiasso,  CH 6830
Correspondent Contact Claudio Freti
Regulation Number878.4400
Classification Product Code
PBX  
Date Received07/13/2018
Decision Date 01/29/2019
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
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