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510(k) K210394

Electrosurgical accessory by Dornier Medtech America, Inc. — Product Code FAS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2021
Date Received
February 10, 2021
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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