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510(k) K211909

Cysto-Gastro-Sets by G-Flex Europe Sprl — Product Code KNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2022
Date Received
June 21, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

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