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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 K053007
Device Name SKYLARK URO PROBE
Applicant
SKYLARK DEVICE & SYSTEMS CO., LTD
4F, 34, SEC. 3,
CHUNG SHAN NORTH RD.
TAIPEI,  TW 104
Applicant Contact GEORGE CHIANG
Correspondent
SKYLARK DEVICE & SYSTEMS CO., LTD
4F, 34, SEC. 3,
CHUNG SHAN NORTH RD.
TAIPEI,  TW 104
Correspondent Contact GEORGE CHIANG
Regulation Number876.5320
Classification Product Code
KPI  
Date Received10/26/2005
Decision Date 12/05/2005
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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