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510(k) K254188

Meniscus Versaflex by GM Dos Reis Industria e Comercio Ltda. — Product Code GAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2026
Date Received
December 23, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polyethylene
Device Class
Class II
Regulation Number
878.5000
Review Panel
SU
Submission Type

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