The following data is part of a premarket notification filed by Pfm Produkte Fur Die Medizin Ag with the FDA for Jetcan Huber Neeedle Set.
| Device ID | K002471 |
| 510k Number | K002471 |
| Device Name: | JETCAN HUBER NEEEDLE SET |
| Classification | Set, Administration, Intravascular |
| Applicant | PFM PRODUKTE FUR DIE MEDIZIN AG 15 CHEROKEE ST. Trabuco Canyon, CA 92679 |
| Contact | Salvadore F Palomares |
| Correspondent | Salvadore F Palomares PFM PRODUKTE FUR DIE MEDIZIN AG 15 CHEROKEE ST. Trabuco Canyon, CA 92679 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-11 |
| Decision Date | 2000-10-19 |