The following data is part of a premarket notification filed by Del Medical Imaging Corp. with the FDA for Mamex.
Device ID | K992037 |
510k Number | K992037 |
Device Name: | MAMEX |
Classification | System, X-ray, Mammographic |
Applicant | DEL MEDICAL IMAGING CORP. 11550 WEST KING ST. Franklin Park, IL 60131 |
Contact | Jeffrey N Moeller |
Correspondent | Jeffrey N Moeller DEL MEDICAL IMAGING CORP. 11550 WEST KING ST. Franklin Park, IL 60131 |
Product Code | IZH |
CFR Regulation Number | 892.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-06-16 |
Decision Date | 1999-07-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MAMEX 74072490 1769215 Dead/Cancelled |
Orion Corporation 1990-06-25 |