Name: Predicase
Price: 199 USD

K-number	K092491
Device name	MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES
Applicant	Medefil, Inc.
Product code	NZW
Device class	Class II
Decision date	Feb 3, 2010
Decision	Substantially Equivalent
Regulation	880.5200

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Source

View the full FDA submission: accessdata.fda.gov

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MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES

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