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510(k) Data Aggregation
K Number
K152038Device Name
MammoGRIP
Manufacturer
Women's Imaging Solutions Enterprises LLC
Date Cleared
2015-12-22
(153 days)
Product Code
IZH
Regulation Number
892.1710Why did this record match?
Applicant Name (Manufacturer) :
Women's Imaging Solutions Enterprises LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MammoGRIP aids in positioning during radiologic visualization of the breast.
Device Description
MammoGRIP™ is a non-medicated, 0.1% benzalkonium chloride foam solution intended to be used during mammography to facilitate breast positioning. When MammoGRIP is applied to the technician's hands, it imparts a slightly tacky or sticky surface while it is still damp, thereby allowing the technician to have a better grip of the dry breast tissue for optimal positioning in the field of view of the mammography machine. MammoGRIP is intended to be used with standard mammogram positioning techniques.
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