K-number	DEN150010
Device name	Dignitana AB DigniCap System
Applicant	Dignitana AB
Product code	PMC
Device class	Class II
Decision date	Dec 8, 2015
Decision	Not Substantially Equivalent
Regulation	878.4360

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View the full FDA submission: accessdata.fda.gov

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Dignitana AB DigniCap System

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