The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Femostop Compression Arch, Femostop Pump, Femostop Bilateral Adapter.
Device ID | K983471 |
510k Number | K983471 |
Device Name: | FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER |
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 | 1998-10-02 |
Decision Date | 1999-02-23 |
Summary: | summary |