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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K191312
Device Name Perfect PFE
Applicant
Tenscare, Ltd.
9 Blenheim Rd., Longmead Business Park,
Epsom,  GB KT19 9BE
Applicant Contact Andrew Brown
Correspondent
Tenscare, Ltd.
9 Blenheim Rd., Longmead Business Park,
Epsom,  GB KT19 9BE
Correspondent Contact Andrew Brown
Regulation Number876.5320
Classification Product Code
KPI  
Date Received05/15/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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