Clearance Summary
MY BREAST FRIEND, BREAST SELF-EXAM PAD received FDA 510(k) clearance under submission number K023390, sponsored by Mbf Sales, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-11-26.
- Submission: K023390
- Applicant / Sponsor: Mbf Sales, LLC
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1940
- Decision date: 2002-11-26
Classification & Regulation
This clearance is catalogued under FDA product code IXH and 21 CFR 892.1940, within the Radiology review panel as a Class I device.