The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Leukoclip(r).
| Device ID | K873744 |
| 510k Number | K873744 |
| Device Name: | LEUKOCLIP(R) |
| Classification | Clip, Removable (skin) |
| Applicant | BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Contact | Vincent Milano |
| Correspondent | Vincent Milano BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Product Code | FZQ |
| CFR Regulation Number | 878.4320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-16 |
| Decision Date | 1987-09-30 |