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510(k) K152092

Resection Electrodes by Olympus Winter & Ibe GmbH — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2015
Date Received
July 28, 2015
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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