K-number	K884505
Device name	BASAL/BOLUS INFUSORS
Applicant	Baxter Healthcare Corp
Product code	FRN
Device class	Class II
Decision date	Jul 14, 1989
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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BASAL/BOLUS INFUSORS

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