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510(k) Data Aggregation
K Number
K022861Device Name
SAFETOUCH
Manufacturer
Date Cleared
2002-11-26
(90 days)
Product Code
Regulation Number
884.2990Why did this record match?
Product Code :
NHM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SafeTouch sheet and marking pen are used to mark the location of breast lumps that a woman may find while doing her monthly breast selfexamination.
Device Description
SafeTouch® Breast Exam Recording Sheet
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K Number
K014300Device Name
SAFETOUCH
Manufacturer
Date Cleared
2002-03-01
(60 days)
Product Code
Regulation Number
884.2990Why did this record match?
Product Code :
NHM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
SafeTouch is intended as an aide in relocating points of interest discovered upon the human body, once they are found. A typical application would be to indicate the location of discovered human breast lumps.
Device Description
Thin plastic film with a preprinted numbered grid and orientation markings
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