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510(k) Data Aggregation
K Number
K070344Device Name
LIV BREAST SELF EXAMINATION AID
Manufacturer
Date Cleared
2007-03-08
(30 days)
Product Code
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
LIV INTERNATIONAL USA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations.
Device Description
The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations. The device is made of soft, latex-free 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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