K-number	K111692
Device name	TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC
Applicant	Somatex Medical Technologies GmbH
Product code	NEU
Device class	Class II
Decision date	Nov 8, 2011
Decision	Substantially Equivalent
Regulation	878.4300

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View the full FDA submission: accessdata.fda.gov

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TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC

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