The following data is part of a premarket notification filed by Landos, Inc. with the FDA for Nancy Nail.
| Device ID | K960642 |
| 510k Number | K960642 |
| Device Name: | NANCY NAIL |
| Classification | Pin, Fixation, Smooth |
| Applicant | LANDOS, INC. 100 LINDENWOOD DR. Malvern, PA 19355 |
| Contact | Jean-paul Burtin |
| Correspondent | Jean-paul Burtin LANDOS, INC. 100 LINDENWOOD DR. Malvern, PA 19355 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-14 |
| Decision Date | 1996-05-17 |
| Summary: | summary |