RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM— 510(k) K040996

Name: FDA 510(k) clearance K040996
Creator: U.S. Food and Drug Administration
Published: 2004-08-20

Substantially Equivalent

Gyrus Ent LLC

FDA 510(k) clearance K040996 for RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM, Substantially Equivalent on 2004-08-20. Applicant: Gyrus Ent LLC. Device class: 2.

Clearance details

Applicant: Gyrus Ent LLC
Product code: Code NIX
Device class: Class 2
Regulation: 21 CFR 874.3950
Advisory panel: Ear, Nose, Throat
Date received: 2004-04-16
Decision date: 2004-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bartlett, TN, US

Download summary PDF View on FDA.gov ↗

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