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510(k) K243580

GraftGun Universal Graft Delivery System (GDS) by SurGenTec, LLC — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2025
Date Received
November 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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