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510(k) K223138

AB1 Electrosurgical Instrument, Creo Electrosurgical System by Creo Medical, Ltd. — Product Code NEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2023
Date Received
October 4, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Ablation, Microwave And Accessories
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

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