The following data is part of a premarket notification filed by Dexcowin Co., Ltd with the FDA for Adx4000-l, Dx3000-l.
| Device ID | K083532 |
| 510k Number | K083532 |
| Device Name: | ADX4000-L, DX3000-L |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | DEXCOWIN CO., LTD #708 LE-MEILLEUR TOWN 837-19 GANGNAM-GU Seoul, KR 135-937 |
| Contact | Claude Yang |
| Correspondent | Claude Yang DEXCOWIN CO., LTD #708 LE-MEILLEUR TOWN 837-19 GANGNAM-GU Seoul, KR 135-937 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-28 |
| Decision Date | 2009-03-10 |
| Summary: | summary |