The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Modification To Femostop Femoral Compression System.
| Device ID | K080206 |
| 510k Number | K080206 |
| Device Name: | MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM |
| Classification | Clamp, Vascular |
| 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 | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-28 |
| Decision Date | 2008-02-26 |
| Summary: | summary |