Name: Predicase
Price: 199 USD

K-number	K100998
Device name	1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1
Applicant	Unilife Medical Solutions Limited
Product code	MEG
Device class	Class II
Decision date	Aug 30, 2010
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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1ML UNITRACT 27G X 1/2 TUBERCULIN SYRINGE, MODEL 132BY2-1

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