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510(k) K163090

Plasma Edge System by Chirurgie Innovation — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2017
Date Received
November 4, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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