The following data is part of a premarket notification filed by Pentaferte S.r.l. with the FDA for Pentaferte Single Use Syringes, Model Size=various Sizes.
| Device ID | K002381 |
| 510k Number | K002381 |
| Device Name: | PENTAFERTE SINGLE USE SYRINGES, MODEL SIZE=VARIOUS SIZES |
| Classification | Syringe, Piston |
| Applicant | PENTAFERTE S.R.L. ZONA INDUSTRIALE Campli, Teramo, IT 64012 |
| Contact | Vittorio Servidori |
| Correspondent | Vittorio Servidori PENTAFERTE S.R.L. ZONA INDUSTRIALE Campli, Teramo, IT 64012 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-04 |
| Decision Date | 2001-01-11 |