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FDA 510(k) Application Details - K061541
Device Classification Name
Electrode, Electrosurgical, Active, Urological
More FDA Info for this Device
510(K) Number
K061541
Device Name
Electrode, Electrosurgical, Active, Urological
Applicant
KSEA
600 CORPORATE POINTE
CULVER CITY, CA 90230-7600 US
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Contact
JAMES A LEE
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
FAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/05/2006
Decision Date
08/21/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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