The following data is part of a premarket notification filed by Abigo Medical Ab with the FDA for Sorbact Wound Dressing-ribbon Gauze.
Device ID | K171225 |
510k Number | K171225 |
Device Name: | Sorbact Wound Dressing-Ribbon Gauze |
Classification | Dressing, Wound, Drug |
Applicant | ABIGO Medical AB Ekonomivagen 5 Askim, SE Se-436 33 |
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 | 2017-04-26 |
Decision Date | 2017-08-21 |
Summary: | summary |