K-number	K141252
Device name	GUARDIAN URETHRAL SHEATH
Applicant	Solace Therapeutics
Product code	KNY
Device class	Class II
Decision date	Jun 9, 2014
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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GUARDIAN URETHRAL SHEATH

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