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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 K032988
Device Name ELPHA 4 CONTI
Applicant
Danmeter A/S
Kildemosevej 13
Odense C,  DK DK-5000
Applicant Contact HANNE NIELSEN
Correspondent
Danmeter A/S
Kildemosevej 13
Odense C,  DK DK-5000
Correspondent Contact HANNE NIELSEN
Regulation Number876.5320
Classification Product Code
KPI  
Date Received09/24/2003
Decision Date 12/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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