K-number	K152597
Device name	ProteXsure Safety Capsule System
Applicant	Starcap Medical, LLC ( Dba Prism Medical & Design)
Product code	FMI
Device class	Class II
Decision date	Jun 8, 2016
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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ProteXsure Safety Capsule System

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