MY BREAST FRIEND, BREAST SELF-EXAM PAD


Device Classification Name

camera, focal spot, radiographic

510(k) Number K023390
Device Name MY BREAST FRIEND, BREAST SELF-EXAM PAD
Original Applicant
MBF SALES, LLC
7361 calhoun place
suite 500
rockville, 
MD 
20855 -2765

Original Contact eduardo march
Regulation Number 892.1940
Classification Product Code
IXH  
Date Received 10/09/2002
Decision Date 11/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No