The following data is part of a premarket notification filed by Nemera with the FDA for Safe'n'sound Staked Passive Delivery System - Plajex Version.
| Device ID | K150562 |
| 510k Number | K150562 |
| Device Name: | Safe'n'Sound Staked Passive Delivery System - Plajex Version |
| Classification | Syringe, Antistick |
| Applicant | Nemera 600 Deerfield Parkway Buffalo Grove, IL 60089 |
| Contact | James A Werkamp |
| Correspondent | Beatrice Grand Demars Nemera 20 Avenue De La Gare La Verpilliere, FR 38292 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-06 |
| Decision Date | 2015-06-02 |
| Summary: | summary |