The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Cutinova Gelfilm Synthetic Wound Dressing, Sterile.
| Device ID | K850147 |
| 510k Number | K850147 |
| Device Name: | CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE |
| Classification | Dressing, Wound, Drug |
| Applicant | BEIERSDORF, INC. 360 MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 |
| Contact | John Trembley |
| Correspondent | John Trembley 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-07-05 |