The following data is part of a premarket notification filed by Diacor, Inc. with the FDA for Mammorx.
Device ID | K930246 |
510k Number | K930246 |
Device Name: | MAMMORX |
Classification | Accelerator, Linear, Medical |
Applicant | DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109 |
Contact | Glenn N Waterman |
Correspondent | Glenn N Waterman DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109 |
Product Code | IYE |
CFR Regulation Number | 892.5050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-19 |
Decision Date | 1993-07-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MAMMORX 77841252 3855806 Live/Registered |
ORFIT INDUSTRIES, NAAMLOZE VENNOOTSCHAP 2009-10-05 |
MAMMORX 74228819 1764339 Dead/Cancelled |
Diacor, Inc. 1991-12-09 |