The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Leukoplast(r) Porous And Sport Tape.
| Device ID | K864160 |
| 510k Number | K864160 |
| Device Name: | LEUKOPLAST(R) POROUS AND SPORT TAPE |
| Classification | Tape And Bandage, Adhesive |
| 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 | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-23 |
| Decision Date | 1986-11-17 |