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510(k) K222025

G4Derm / G4Derm Plus Synthetic Wound Matrix by Gel4med, Inc. — Product Code FRO

K222025 is an FDA 510(k) premarket notification submitted by Gel4med, Inc. for the device "G4Derm / G4Derm Plus Synthetic Wound Matrix". The FDA issued a decision of Substantially Equivalent on October 11, 2023. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2023
Date Received
July 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

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FDA data resources