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Medline ART Skin Harvesting System

DEN210049 Class II Direct
Decision Date
2024-03-27
Sponsor / Applicant
Medline Industries, Inc.

Technical Specification

510(k) Submission ID DEN210049
Product Code QYK
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4795
Decision Date 2024-03-27
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Medline ART Skin Harvesting System received FDA 510(k) clearance under submission number DEN210049, sponsored by Medline Industries, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-03-27.

Classification & Regulation

This clearance is catalogued under FDA product code QYK and 21 CFR 878.4795, within the General, Plastic Surgery review panel as a Class II device.