The following data is part of a premarket notification filed by Bsn Medical Gmbh with the FDA for Cutimed Sorbact Wound Dressings (cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact).
| Device ID | K143151 |
| 510k Number | K143151 |
| Device Name: | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact) |
| Classification | Dressing, Wound, Drug |
| Applicant | BSN MEDICAL GMBH QUICKBORNSTRASSE 24 Hamburg, DE 20253 |
| Contact | Martin Spengler |
| Correspondent | Marcia Palma NAMSA 4050 OLSON MEMORIAL HIGHWAY, SUITE 450 Minneapolis, MN 55422 |
| 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 | 2014-11-03 |
| Decision Date | 2015-01-26 |
| Summary: | summary |