The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Curad Wound Dressings.
| Device ID | K093349 |
| 510k Number | K093349 |
| Device Name: | MEDLINE CURAD WOUND DRESSINGS |
| 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 | 2009-10-27 |
| Decision Date | 2010-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30749756912113 | K093349 | 000 |
| 30749756567504 | K093349 | 000 |
| 30749756567498 | K093349 | 000 |