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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 -3442
Applicant Contact BARBARA SARKIS
Correspondent
ATHENA FEMININE TECHNOLOGIES, INC.
179 MORAGA WAY
ORINDA,  CA  94563 -3442
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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