The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Cutifilm(r) Film.
| Device ID | K926399 |
| 510k Number | K926399 |
| Device Name: | CUTIFILM(R) FILM |
| Classification | Dressing, Wound And Burn, Occlusive |
| 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 | MGP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-21 |
| Decision Date | 1993-11-15 |