The following data is part of a premarket notification filed by Coramex, S.a. with the FDA for Corix 70 Plus-usv.
| Device ID | K031802 |
| 510k Number | K031802 |
| Device Name: | CORIX 70 PLUS-USV |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | CORAMEX, S.A. 251 E. DUNDEE ROAD SUITE #6 Wheeling, IL 60090 |
| Contact | Al Sosa |
| Correspondent | Al Sosa CORAMEX, S.A. 251 E. DUNDEE ROAD SUITE #6 Wheeling, IL 60090 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-11 |
| Decision Date | 2003-07-21 |
| Summary: | summary |