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510(k) K240722

Derma-R Cream (Derma-R Cream) by Raya Pharmaceuticals, LLC — Product Code FRO

K240722 is an FDA 510(k) premarket notification submitted by Raya Pharmaceuticals, LLC for the device "Derma-R Cream (Derma-R Cream)". The FDA issued a decision of Substantially Equivalent on September 20, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 2024
Date Received
March 18, 2024
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