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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Focal Spot, Radiographic
510(k) Number K023390
Device Name MY BREAST FRIEND, BREAST SELF-EXAM PAD
Applicant
Mbf Sales, LLC
7361 Calhoun Pl., Suite 500
Rockville,  MD  20855
Applicant Contact EDUARDO MARCH
Correspondent
Mbf Sales, LLC
7361 Calhoun Pl., Suite 500
Rockville,  MD  20855
Correspondent Contact EDUARDO MARCH
Regulation Number892.1940
Classification Product Code
IXH  
Date Received10/09/2002
Decision Date 11/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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