510(k) K240722
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 Sep 20, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 20, 2024
- Date Received
- Mar 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