Name: Predicase
Price: 199 USD

K-number	K912613
Device name	GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)
Applicant	Sensititre Microbiology A Div. of Radiometer
Product code	JWY
Device class	Class II
Decision date	Aug 22, 1991
Decision	Substantially Equivalent
Regulation	866.1640

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Source

View the full FDA submission: accessdata.fda.gov

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GENTAMICIN 500 UG/ML TO BE INCLUDED IN JUSTONE(TM)

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