The following data is part of a premarket notification filed by Hennig Enterprises Europe S.r.l. with the FDA for V Set.
Device ID | K020424 |
510k Number | K020424 |
Device Name: | V SET |
Classification | Set, Administration, Intravascular |
Applicant | HENNIG ENTERPRISES EUROPE S.R.L. 25 SHANN ST., FLOREAT Perth, AU 6014 |
Contact | George O'neil |
Correspondent | George O'neil HENNIG ENTERPRISES EUROPE S.R.L. 25 SHANN ST., FLOREAT Perth, AU 6014 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-02-08 |
Decision Date | 2003-08-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() V SET 75914139 not registered Dead/Abandoned |
Cotton, Jack 2000-02-10 |