510(k) K240510
K240510 is an FDA 510(k) premarket notification submitted by Sonoma Pharmaceuticals, Inc. for the device "Microdacyn Hydrogel". The FDA issued a decision of Substantially Equivalent on Nov 8, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Sonoma Pharmaceuticals, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 8, 2024
- Date Received
- Feb 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)