Name: Predicase
Price: 199 USD

K-number	K112936
Device name	SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM
Applicant	Rexam Consummer Plastics Inc.D/B/A Rexam Pharma
Product code	MEG
Device class	Class II
Decision date	Jan 20, 2012
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM

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