The following data is part of a premarket notification filed by Elwyn, Inc. with the FDA for Variously Sized Sterile Cotton Wound Dressings.
| Device ID | K891133 |
| 510k Number | K891133 |
| Device Name: | VARIOUSLY SIZED STERILE COTTON WOUND DRESSINGS |
| Classification | Dressing, Wound, Drug |
| Applicant | ELWYN, INC. Elwyn, PA 19063 |
| Contact | A Washington |
| Correspondent | A Washington ELWYN, INC. Elwyn, PA 19063 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-03 |
| Decision Date | 1989-05-24 |