meddevicedb.com FDA Device Reference

PRINEO SKIN CLOSURE SYSTEM

DEN090005 Class II Post-NSE
Decision Date
2010-04-30
Sponsor / Applicant
Closure Medical Corp.

Technical Specification

510(k) Submission ID DEN090005
Product Code OMD
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4011
Decision Date 2010-04-30
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

PRINEO SKIN CLOSURE SYSTEM received FDA 510(k) clearance under submission number DEN090005, sponsored by Closure Medical Corp.. 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 2010-04-30.

Classification & Regulation

This clearance is catalogued under FDA product code OMD and 21 CFR 878.4011, within the General, Plastic Surgery review panel as a Class II device.