The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Modification To: Titanium Telegraph Humeral Nail.
| Device ID | K052058 |
| 510k Number | K052058 |
| Device Name: | MODIFICATION TO: TITANIUM TELEGRAPH HUMERAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Contact | Christine Quendez |
| Correspondent | Christine Quendez FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL Quimper, FR 29000 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-29 |
| Decision Date | 2005-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489539886 | K052058 | 000 |
| 03661489539879 | K052058 | 000 |
| 03661489539862 | K052058 | 000 |
| 03661489539855 | K052058 | 000 |