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FDA 510(k) Application Details - K070331
Device Classification Name
Stimulator, Electrical, Non-Implantable, For Incontinence
More FDA Info for this Device
510(K) Number
K070331
Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant
LABORIE MEDICAL TECHNOLOGIES
400 AVENUE D SUITE 10
WILLISTON, VT 05495 US
Other 510(k) Applications for this Company
Contact
BARBARA MORNET
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
02/05/2007
Decision Date
05/04/2007
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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