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RETROX

DEN020003 Class II Post-NSE
Decision Date
2002-08-20
Sponsor / Applicant
Auric Hearing Systems, Inc.

Technical Specification

510(k) Submission ID DEN020003
Product Code NIX
Medical Specialty / Panel Ear, Nose, Throat
Regulation Citation 21 CFR 874.3950
Decision Date 2002-08-20
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

RETROX received FDA 510(k) clearance under submission number DEN020003, sponsored by Auric Hearing Systems, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2002-08-20.

Classification & Regulation

This clearance is catalogued under FDA product code NIX and 21 CFR 874.3950, within the Ear, Nose, Throat review panel as a Class II device.