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510(k) K061541

KSEA BIPOLAR ELECTROTOME by Ksea — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2006
Date Received
June 5, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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