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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 K122194
Device Name LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
Original Applicant
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
3 fl., no. 5, lane 155, sec.3,
peishen rd.
shen keng hsiang,taipei hsien,  TW 222
Original Contact robert tu
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HIR  
Date Received07/24/2012
Decision Date 04/04/2013
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
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