The following data is part of a premarket notification filed by Abigo Medical Ab with the FDA for Sorbact Wound Dressing.
| Device ID | K063059 |
| 510k Number | K063059 |
| Device Name: | SORBACT WOUND DRESSING |
| Classification | Dressing, Wound, Drug |
| Applicant | ABIGO MEDICAL AB 1601 K STREET NW Washington, DC 20006 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy ABIGO MEDICAL AB 1601 K STREET NW Washington, DC 20006 |
| 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 | 2006-10-05 |
| Decision Date | 2007-04-19 |
| Summary: | summary |