The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Cutinova Thin Wound Dressing.
| Device ID | K944581 |
| 510k Number | K944581 |
| Device Name: | CUTINOVA THIN WOUND DRESSING |
| Classification | Bandage, Liquid |
| Applicant | BEIERSDORF, INC. 360 DR. MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 -5529 |
| Contact | Kenneth M Nicoll |
| Correspondent | Kenneth M Nicoll BEIERSDORF, INC. 360 DR. MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 -5529 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1994-12-02 |