The following data is part of a premarket notification filed by Mbf Sales, Llc with the FDA for My Breast Friend, Breast Self-exam Pad.
| Device ID | K023390 |
| 510k Number | K023390 |
| Device Name: | MY BREAST FRIEND, BREAST SELF-EXAM PAD |
| Classification | Camera, Focal Spot, Radiographic |
| Applicant | MBF SALES, LLC 7361 CALHOUN PLACE SUITE 500 Rockville, MD 20855 -2765 |
| Contact | Eduardo March |
| Correspondent | Eduardo March MBF SALES, LLC 7361 CALHOUN PLACE SUITE 500 Rockville, MD 20855 -2765 |
| Product Code | IXH |
| CFR Regulation Number | 892.1940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-09 |
| Decision Date | 2002-11-26 |
| Summary: | summary |