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510(k) Data Aggregation
K Number
K071787Device Name
BEMITT, MODEL 0001
Manufacturer
Date Cleared
2007-10-26
(116 days)
Product Code
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
DJA DISTRIBUTORS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BeMitt™ Self Breast Exam is indicated as an aid for performing breast-self examinations.
Device Description
The BeMitt™ Self Breast Exam is indicated as an aid for performing breastself examinations. The device is made of conformable polyurethane and filled with a non-toxic lubricant. While allowing the breast tissue to remain in place during an exam, your fingers can still move effortlessly across the breast while detecting abnormalities.
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