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FDA 510(k) Application Details - K033256
Device Classification Name
Stimulator, Electrical, Non-Implantable, For Incontinence
More FDA Info for this Device
510(K) Number
K033256
Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant
ATHENA FEMININE TECHNOLOGIES, INC.
179 MORAGA WAY
ORINDA, CA 94563-3442 US
Other 510(k) Applications for this Company
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
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/09/2003
Decision Date
12/30/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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