Name: Predicase
Price: 199 USD

K-number	K080934
Device name	VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET
Applicant	Nucletron Corporation
Product code	JAQ
Device class	Class II
Decision date	May 28, 2008
Decision	Substantially Equivalent
Regulation	892.5700

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Source

View the full FDA submission: accessdata.fda.gov

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VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET

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