The following data is part of a premarket notification filed by Gyrus Ent L.l.c. with the FDA for Retrox Titanium Tube System For The Retrox Transcutaneous Air Conduction Hearing Aid System.
| Device ID | K040996 |
| 510k Number | K040996 |
| Device Name: | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM |
| Classification | Hearing Aid, Air Conduction, Transcutaneous System |
| Applicant | GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Contact | Alicia E Farage |
| Correspondent | Alicia E Farage GYRUS ENT L.L.C. 2925 APPLING RD. Bartlett, TN 38133 |
| Product Code | NIX |
| CFR Regulation Number | 874.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-16 |
| Decision Date | 2004-08-20 |
| Summary: | summary |