Name: Predicase
Price: 199 USD

K-number	K972728
Device name	STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	FMF
Device class	Class II
Decision date	Jul 15, 1998
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)

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