The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Cutinova(r) Plus On Vascular Stasis Ulcers.
| Device ID | K885279 |
| 510k Number | K885279 |
| Device Name: | CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-23 |
| Decision Date | 1989-06-13 |