510(k) K213473
K213473 is an FDA 510(k) premarket notification submitted by Advanced Medical Solutions, Ltd. for the device "Antimicrobial Gelling Fiber Dressing with PHMB". The FDA issued a decision of Substantially Equivalent on October 26, 2023. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Advanced Medical Solutions, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2023
- Date Received
- October 28, 2021
- 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