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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 K964738
Device Name ELPHA 2000 CONTI
Applicant
Dan Med, Inc.
4450 Arapahoe Ave.
Boulder,  CO  80303
Applicant Contact THOMAS SANDGAARD
Correspondent
Dan Med, Inc.
4450 Arapahoe Ave.
Boulder,  CO  80303
Correspondent Contact THOMAS SANDGAARD
Regulation Number876.5320
Classification Product Code
KPI  
Date Received11/13/1996
Decision Date 08/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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