The following data is part of a premarket notification filed by Dks Loversan Industria Biomedica Spa with the FDA for Microflo-safe Scalp Vein Set.
| Device ID | K043328 |
| 510k Number | K043328 |
| Device Name: | MICROFLO-SAFE SCALP VEIN SET |
| Classification | Set, Administration, Intravascular |
| Applicant | DKS LOVERSAN INDUSTRIA BIOMEDICA SPA 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Contact | Arthur Ward |
| Correspondent | Arthur Ward DKS LOVERSAN INDUSTRIA BIOMEDICA SPA 962 ALLEGRO LANE Apollo Beach, FL 33572 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-02 |
| Decision Date | 2005-04-15 |
| Summary: | summary |