K-number	K070939
Device name	SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM
Applicant	Coloplast Manufacturing Us, LLC
Product code	FCM
Device class	Class II
Decision date	Jun 1, 2007
Decision	Substantially Equivalent
Regulation	876.5130

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View the full FDA submission: accessdata.fda.gov

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SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

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