510(k) K233151
K233151 is an FDA 510(k) premarket notification submitted by Medline Industries, LP for the device "PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)". The FDA issued a decision of Substantially Equivalent on March 26, 2024. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Medline Industries, LP has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 2024
- Date Received
- September 27, 2023
- 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