The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Leukoflex Surgical Tape.
| Device ID | K843876 |
| 510k Number | K843876 |
| Device Name: | LEUKOFLEX SURGICAL TAPE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | BEIERSDORF, INC. P.O. BOX 5529 Norwalk , CT 06856 - |
| Contact | John R Trembley |
| Correspondent | John R Trembley BEIERSDORF, INC. 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 | 1984-10-02 |
| Decision Date | 1985-02-21 |