The following data is part of a premarket notification filed by Beiersdorf, Inc. with the FDA for Cutiplast Steril.
| Device ID | K943363 |
| 510k Number | K943363 |
| Device Name: | CUTIPLAST STERIL |
| Classification | Dressing, Wound And Burn, Occlusive |
| Applicant | BEIERSDORF, INC. 360 DR. MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 -5529 |
| Contact | Elizabeth H Anderson |
| Correspondent | Elizabeth H Anderson BEIERSDORF, INC. 360 DR. MARTIN LUTHER KING DR. P.O. BOX 5529 Norwalk, CT 06856 -5529 |
| 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 | 1994-07-13 |
| Decision Date | 1995-03-15 |