The following data is part of a premarket notification filed by Abigo Medical Ab with the FDA for Sorbact Foam Gentle Border, Sorbact Superabsorbent.
| Device ID | K153674 |
| 510k Number | K153674 |
| Device Name: | Sorbact Foam Gentle Border, Sorbact Superabsorbent |
| Classification | Dressing, Wound, Drug |
| Applicant | ABIGO Medical AB Ekonomivagen 5 Askim, SE Se-43633 |
| Contact | Annica Corbe |
| Correspondent | Deborah Lavoie Grayeski M Squared Associates, Inc. 575 8th Avenue, Suite 1212 New York, NY 10018 |
| 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 | 2015-12-21 |
| Decision Date | 2016-07-01 |
| Summary: | summary |