The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Topseal Hemostatic Dressing, Model 11150.
| Device ID | K033291 |
| 510k Number | K033291 |
| Device Name: | TOPSEAL HEMOSTATIC DRESSING, MODEL 11150 |
| Classification | Dressing, Wound, Drug |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Helene Ekstrand |
| Correspondent | Helene Ekstrand RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| 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 | 2003-10-14 |
| Decision Date | 2004-03-17 |
| Summary: | summary |