The following data is part of a premarket notification filed by Fournitures Hospitalieres Industrie with the FDA for Snap-off Screws.
| Device ID | K041456 |
| 510k Number | K041456 |
| Device Name: | SNAP-OFF SCREWS |
| Classification | Screw, Fixation, Bone |
| 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-01 |
| Decision Date | 2004-08-25 |