The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Luekoflex Surgical Tape.
| Device ID | K923404 |
| 510k Number | K923404 |
| Device Name: | LUEKOFLEX SURGICAL TAPE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-10 |
| Decision Date | 1992-09-09 |