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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 K033256
Device Name ATHENA PELVIC MUSCLE TRAINER II
Applicant
Athena Feminine Technologies, Inc.
179 Moraga Way
Orinda,  CA  94563
Applicant Contact BARBARA SARKIS
Correspondent
Athena Feminine Technologies, Inc.
179 Moraga Way
Orinda,  CA  94563
Correspondent Contact BARBARA SARKIS
Regulation Number876.5320
Classification Product Code
KPI  
Date Received10/09/2003
Decision Date 12/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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