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510(k) K242835

Suture-TOOL System by Suturion AB — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2025
Date Received
September 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

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