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510(k) K102781

RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATION, HF-RESECTION ELECTRODE ROLLERS AND NEEDLES, LOOPS AND BANDS by Olympus Winter & Ibe GmbH — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2011
Date Received
September 27, 2010
Clearance Type
Special
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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