The following data is part of a premarket notification filed by Union Medico Aps with the FDA for Personal Injector.
| Device ID | K033696 |
| 510k Number | K033696 |
| Device Name: | PERSONAL INJECTOR |
| Classification | Introducer, Syringe Needle |
| Applicant | UNION MEDICO APS EMDRUPVEJ 22 Copenhagen, DK 2100 |
| Contact | Michael Perthu |
| Correspondent | Michael Perthu UNION MEDICO APS EMDRUPVEJ 22 Copenhagen, DK 2100 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-25 |
| Decision Date | 2005-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05714472000004 | K033696 | 000 |