The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Femostop.
Device ID | K915280 |
510k Number | K915280 |
Device Name: | FEMOSTOP |
Classification | Clamp, Vascular |
Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
Contact | Goran Liljenstrom |
Correspondent | Goran Liljenstrom 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 | 1991-11-25 |
Decision Date | 1992-04-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() FEMOSTOP 74460108 1898768 Live/Registered |
ST. JUDE MEDICAL COORDINATION CENTER BVBA 1993-11-18 |