The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Femostop Ii Plus Disposable Set Model 11166, Femostop Ii Plus Compression Arch Model 11168, Femostop Ii Bilateral Adapt0.
| Device ID | K982182 |
| 510k Number | K982182 |
| Device Name: | FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0 |
| Classification | Clamp, Vascular |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Mats Granlund |
| Correspondent | Mats Granlund RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-22 |
| Decision Date | 1998-09-18 |
| Summary: | summary |