Name: Predicase
Price: 199 USD

K-number	K083667
Device name	NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337
Applicant	B-K Medical Aps
Product code	ITX
Device class	Class II
Decision date	Feb 2, 2009
Decision	Substantially Equivalent
Regulation	892.1570

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Source

View the full FDA submission: accessdata.fda.gov

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NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337

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