510(k) K023390
K023390 is an FDA 510(k) premarket notification submitted by Mbf Sales, LLC for the device "MY BREAST FRIEND, BREAST SELF-EXAM PAD". The FDA issued a decision of Substantially Equivalent on November 26, 2002. The device falls under product code IXH (Camera, Focal Spot, Radiographic), a Class I device regulated under 21 CFR 892.1940.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 2002
- Date Received
- October 9, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Focal Spot, Radiographic
- Device Class
- Class I
- Regulation Number
- 892.1940
- Review Panel
- RA
- Submission Type