The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Titanium Telegraph Humeral Nail.
| Device ID | K042332 |
| 510k Number | K042332 |
| Device Name: | 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2004-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03661489508493 | K042332 | 000 |
| 03661489507014 | K042332 | 000 |
| 03661489507007 | K042332 | 000 |
| 03661489506994 | K042332 | 000 |
| 03661489506987 | K042332 | 000 |
| 03661489506970 | K042332 | 000 |
| 03661489506963 | K042332 | 000 |
| 03661489506956 | K042332 | 000 |
| 03661489506949 | K042332 | 000 |
| 03661489506932 | K042332 | 000 |
| 03661489507281 | K042332 | 000 |
| 03661489507250 | K042332 | 000 |
| 03661489507229 | K042332 | 000 |
| 03661489507205 | K042332 | 000 |
| 03661489507175 | K042332 | 000 |
| 03661489507168 | K042332 | 000 |
| 03661489507021 | K042332 | 000 |
| 03661489507038 | K042332 | 000 |
| 03661489507045 | K042332 | 000 |
| 03661489508479 | K042332 | 000 |
| 03661489508455 | K042332 | 000 |
| 03661489508431 | K042332 | 000 |
| 03661489508417 | K042332 | 000 |
| 03661489508394 | K042332 | 000 |
| 03661489508370 | K042332 | 000 |
| 03661489507137 | K042332 | 000 |
| 03661489507120 | K042332 | 000 |
| 03661489507113 | K042332 | 000 |
| 03661489507106 | K042332 | 000 |
| 03661489507090 | K042332 | 000 |
| 03661489507083 | K042332 | 000 |
| 03661489507076 | K042332 | 000 |
| 03661489507069 | K042332 | 000 |
| 03661489507052 | K042332 | 000 |
| 03661489507144 | K042332 | 000 |