meddevicedb.com FDA Device Reference

MOERAE SURGICAL MARKING PEN

DEN130004 Class II Post-NSE
Decision Date
2014-12-18
Sponsor / Applicant
Moerae Matrix, Inc.

Technical Specification

510(k) Submission ID DEN130004
Product Code PDW
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4670
Decision Date 2014-12-18
Clearance Pathway Post-NSE

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

MOERAE SURGICAL MARKING PEN received FDA 510(k) clearance under submission number DEN130004, sponsored by Moerae Matrix, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2014-12-18.

Classification & Regulation

This clearance is catalogued under FDA product code PDW and 21 CFR 878.4670, within the General, Plastic Surgery review panel as a Class II device.