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510(k) K240127

PlumeSafe X5 Smoke Management System by Conmed Corporation — Product Code FYD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2024
Date Received
January 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Exhaust, Surgical
Device Class
Class II
Regulation Number
878.5070
Review Panel
HO
Submission Type

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