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510(k) Data Aggregation
K Number
K023390Device Name
MY BREAST FRIEND, BREAST SELF-EXAM PAD
Manufacturer
MBF SALES, LLC
Date Cleared
2002-11-26
(48 days)
Product Code
IXH
Regulation Number
892.1940Why did this record match?
Applicant Name (Manufacturer) :
MBF SALES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
My Breast Friend Breast Self-exam Pad is indicated as an aid for performing breast selfexamination.
Device Description
The My Breast Friend Breast Self-exam Pad is a thin polyurethane bladder containing a small quantity of silicone and air fluids. The very thin nature of the material allows the pad to conform to the patient's breast tissue and for the patient to observe a reduction in friction. The very thin and flexible bladder provides easy sliding between the upper and lower surfaces of the bladder and allows the patient to sense subtle tissue density variations.
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