The following data is part of a premarket notification filed by Terumo Europe N.v. with the FDA for Neolus Needle.
| Device ID | K001572 |
| 510k Number | K001572 |
| Device Name: | NEOLUS NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 INTERLEUVENLAAN 40 Leuven 3001, BE 3001 |
| Contact | M J Aerts |
| Correspondent | M J Aerts TERUMO EUROPE N.V. RESEARCHPARK ZONE 2 INTERLEUVENLAAN 40 Leuven 3001, BE 3001 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-22 |
| Decision Date | 2000-08-14 |