The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Curad Antibacterial Bandage.
| Device ID | K113583 |
| 510k Number | K113583 |
| Device Name: | CURAD ANTIBACTERIAL BANDAGE |
| Classification | Dressing, Wound, Drug |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-12-05 |
| Decision Date | 2012-04-12 |