The following data is part of a premarket notification filed by Artsana S.p.a with the FDA for Safe Block Pen Needle.
| Device ID | K151311 |
| 510k Number | K151311 |
| Device Name: | Safe Block Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Artsana S.P.A Via Saldarini Catelli 1 Grandate, IT 22070 |
| Contact | Cassani Mauro |
| Correspondent | H. Carl Jenkins Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff, IL 60044 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2016-02-10 |
| Summary: | summary |