The following data is part of a premarket notification filed by Medicalex with the FDA for Lere Nail & Plate Combin. One Piece Forged.
| Device ID | K851349 |
| 510k Number | K851349 |
| Device Name: | LERE NAIL & PLATE COMBIN. ONE PIECE FORGED |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | MEDICALEX 39 RUE CROULEBARBE Paris 75013, FR |
| Contact | Aldo Levy |
| Correspondent | Aldo Levy MEDICALEX 39 RUE CROULEBARBE Paris 75013, FR |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-04 |
| Decision Date | 1985-05-29 |