The following data is part of a premarket notification filed by Dxm Co., Ltd. with the FDA for Denjector.
| Device ID | K081694 |
| 510k Number | K081694 |
| Device Name: | DENJECTOR |
| Classification | Syringe, Cartridge |
| Applicant | DXM CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Maria Griffin |
| Correspondent | Maria Griffin DXM CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | EJI |
| CFR Regulation Number | 872.6770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-17 |
| Decision Date | 2008-09-12 |
| Summary: | summary |