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 |