Medline ART Skin Harvesting System
FDA 510(k) clearance DEN210049 · decided 2024-03-27
Clearance details
- K-number
- DEN210049
- Device name
- Medline ART Skin Harvesting System
- Applicant
- Medline Industries, Inc.
- Decision
- Unknown
- Date received
- 2021-10-19
- Decision date
- 2024-03-27
- Days to decision
- 890 days
- Clearance type
- Direct
- Product code
- QYK
- Device class
- 2
- Regulation number
- 878.4795
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Northfiled, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.