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 |