The following data is part of a premarket notification filed by Surgical Implant Generation Network (sign) with the FDA for Sign Fin Nail.
| Device ID | K043200 |
| 510k Number | K043200 |
| Device Name: | SIGN FIN NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SURGICAL IMPLANT GENERATION NETWORK (SIGN) 2950 GEORGE WASHINGTON WAY Richland, WA 99352 -1615 |
| Contact | Douglas J Donnelly |
| Correspondent | Douglas J Donnelly SURGICAL IMPLANT GENERATION NETWORK (SIGN) 2950 GEORGE WASHINGTON WAY Richland, WA 99352 -1615 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-18 |
| Decision Date | 2005-02-03 |
| Summary: | summary |