The following data is part of a premarket notification filed by Artsana S.p.a. with the FDA for Artsana Pen Needles, Artsana Injection Needles.
| Device ID | K051783 |
| 510k Number | K051783 |
| Device Name: | ARTSANA PEN NEEDLES, ARTSANA INJECTION NEEDLES |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ARTSANA S.P.A. 22411 60TH STREET Bristol, WI 53104 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons ARTSANA S.P.A. 22411 60TH STREET Bristol, WI 53104 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-01 |
| Decision Date | 2005-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50812383030605 | K051783 | 000 |
| 50812383030414 | K051783 | 000 |
| 50812383030421 | K051783 | 000 |
| 50812383030438 | K051783 | 000 |
| 50812383030445 | K051783 | 000 |
| 50812383030452 | K051783 | 000 |
| 50812383030469 | K051783 | 000 |
| 50812383030476 | K051783 | 000 |
| 50812383030506 | K051783 | 000 |
| 50812383030513 | K051783 | 000 |
| 50812383030407 | K051783 | 000 |