The following data is part of a premarket notification filed by Dja Distributors, Llc with the FDA for Bemitt, Model 0001.
| Device ID | K071787 |
| 510k Number | K071787 |
| Device Name: | BEMITT, MODEL 0001 |
| Classification | System, X-ray, Mammographic |
| Applicant | DJA DISTRIBUTORS, LLC 2225 E. FLAMINGO ROAD SUITE 204 Las Vegas, NV 89119 |
| Contact | Beth Bromberg |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-07-02 |
| Decision Date | 2007-10-26 |
| Summary: | summary |