Name: Predicase
Price: 199 USD

K-number	K060339
Device name	KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
Applicant	Tyco Healthcare/Kendall
Product code	NGT
Device class	Class II
Decision date	Apr 28, 2006
Decision	Substantially Equivalent
Regulation	880.5200

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Source

View the full FDA submission: accessdata.fda.gov

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KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY

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