510(k) K190224
K190224 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "Medline Burn and Wound Dressing (OTC)". The FDA issued a decision of Substantially Equivalent on Mar 8, 2019. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Medline Industries, Inc. has 268 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 8, 2019
- Date Received
- Feb 5, 2019
- 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)