Name: Predicase
Price: 199 USD

K-number	K111405
Device name	BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
Applicant	Hangzhou Bever Medical Devices Co., Ltd.
Product code	GBM
Device class	Class II
Decision date	Feb 13, 2012
Decision	Substantially Equivalent
Regulation	876.5130

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Source

View the full FDA submission: accessdata.fda.gov

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BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,

Everything you need for a 510(k) submission. Nothing you don't.