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510(k) K100275

WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS by Olympus Winter & Ibe GmbH — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2010
Date Received
February 1, 2010
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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