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510(k) K192905

Creo Electrosurgical System with HS1 Hemostasis Accessory by Creo Medical, Ltd. — Product Code KNS

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
March 19, 2020
Date Received
October 15, 2019
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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