meddevicedb.com FDA Device Reference

D2 Dressing

DEN160012 Class II Direct
Decision Date
2017-06-30
Sponsor / Applicant
Z-Medica, LLC

Technical Specification

510(k) Submission ID DEN160012
Product Code POD
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4454
Decision Date 2017-06-30
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

D2 Dressing received FDA 510(k) clearance under submission number DEN160012, sponsored by Z-Medica, LLC. 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 2017-06-30.

Classification & Regulation

This clearance is catalogued under FDA product code POD and 21 CFR 878.4454, within the General, Plastic Surgery review panel as a Class II device.