K-number	K121458
Device name	SPEEDICATH COMPACT SET (12/18 FR)
Applicant	Coloplast A/S
Product code	GBM
Device class	Class II
Decision date	Oct 1, 2012
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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SPEEDICATH COMPACT SET (12/18 FR)

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