The following data is part of a premarket notification filed by Mdt Corp., Inc. with the FDA for Raflex 70.
| Device ID | K792437 |
| 510k Number | K792437 |
| Device Name: | RAFLEX 70 |
| Classification | Unit, X-ray, Intraoral |
| Applicant | MDT CORP., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-28 |
| Decision Date | 1980-01-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RAFLEX 70 73253319 1157165 Dead/Cancelled |
MDT Diagnostic Company 1980-03-10 |