The following data is part of a premarket notification filed by Tecnomed, Inc. with the FDA for Tec 2720 Mamex Dc Mag.
| Device ID | K854203 |
| 510k Number | K854203 |
| Device Name: | TEC 2720 MAMEX DC MAG |
| Classification | System, X-ray, Mammographic |
| Applicant | TECNOMED, INC. 235 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Contact | Jean Griswold |
| Correspondent | Jean Griswold TECNOMED, INC. 235 SOUTH FEHR WAY Bay Shore, NY 11706 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-16 |
| Decision Date | 1986-03-06 |