Name: Predicase
Price: 199 USD

K-number	K903732
Device name	KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
Applicant	Kendall Healthcare Products Co. Div.Of Tyco Health
Product code	FOZ
Device class	Class II
Decision date	Oct 3, 1990
Decision	Substantially Equivalent — Same Device
Regulation	880.5200

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Source

View the full FDA submission: accessdata.fda.gov

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KENDALL SAFETRAK(TM) HIGH FLOW CATHETER

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