Name: Predicase
Price: 199 USD

K-number	K914316
Device name	CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH
Applicant	Medi-Flex Hospital Products, Inc.
Product code	LYY
Device class	Class I
Decision date	Dec 24, 1991
Decision	Substantially Equivalent for Some Indications
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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CEPTI-SEAL DRESSING CHANGE KIT FOR CENT VEN CATH

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