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510(k) K240504

PLASMA EDGE System by Lamidey Noury Medical — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2024
Date Received
February 21, 2024
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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