510(k) DEN210049
- Device
- Medline ART Skin Harvesting System
- Applicant
- Medline Industries, Inc.
- 510(k) number
- DEN210049
- Product code
- QYK
- Decision
- Unknown (DENG)
- Decision date
- 2024-03-27
- Date received
- 2021-10-19
- Regulation
- 878.4795
- Classification name
- Semi-Automated Autologous Skin Graft Harvesting And Application Device
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Stephanie Augsburg
- Address
- Three Lakes Dr. Northfiled IL US 60093 60093
FDA Registration Numbers
- 1225492
Source Documents
510(k) summary PDF not indicated by FDA