The following data is part of a premarket notification filed by Dxm Co., Ltd. with the FDA for Hawk Intraoral Camera And Accessories.
| Device ID | K040116 |
| 510k Number | K040116 |
| Device Name: | HAWK INTRAORAL CAMERA AND ACCESSORIES |
| Classification | Unit, Operative Dental |
| Applicant | DXM CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Carolann Kotula |
| Correspondent | Carolann Kotula DXM CO., LTD. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-20 |
| Decision Date | 2004-04-20 |
| Summary: | summary |