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FDA 510(k) Application Details - K023905
Device Classification Name
Stimulator, Electrical, Non-Implantable, For Incontinence
More FDA Info for this Device
510(K) Number
K023905
Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant
ATHENA FEMININE TECHNOLOGIES, INC.
179 MORAGA WAY
ORINDA, CA 92520 US
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Contact
BARBARA SARKIS
Other 510(k) Applications for this Contact
Regulation Number
876.5320
More FDA Info for this Regulation Number
Classification Product Code
KPI
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More FDA Info for this Product Code
Date Received
11/22/2002
Decision Date
04/30/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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