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510(k) K251323

Device 104 Particulate by Geistlich Pharma AG — Product Code KGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2026
Date Received
April 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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