meddevicedb.com FDA Device Reference

TEPHAFLEX ABSORBABLE SUTURE

DEN060003 Class II Post-NSE
Decision Date
2007-02-08
Sponsor / Applicant
Tepha, Inc.

Technical Specification

510(k) Submission ID DEN060003
Product Code NWJ
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4494
Decision Date 2007-02-08
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

TEPHAFLEX ABSORBABLE SUTURE received FDA 510(k) clearance under submission number DEN060003, sponsored by Tepha, 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 2007-02-08.

Classification & Regulation

This clearance is catalogued under FDA product code NWJ and 21 CFR 878.4494, within the General, Plastic Surgery review panel as a Class II device.