The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Tenderwet Active.
| Device ID | K040517 |
| 510k Number | K040517 |
| Device Name: | TENDERWET ACTIVE |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Andrea Haferkamp |
| Correspondent | Andrea Haferkamp MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-27 |
| Decision Date | 2004-03-25 |