Name: Predicase
Price: 199 USD

K-number	K063503
Device name	OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
Applicant	Mallinckrodt Inc., Liebel-Flarsheim Business
Product code	IZQ
Device class	Class II
Decision date	Apr 27, 2007
Decision	Substantially Equivalent
Regulation	870.1650

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Source

View the full FDA submission: accessdata.fda.gov

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OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION

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