Name: Predicase
Price: 199 USD

K-number	K052987
Device name	BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC
Applicant	Noras Rontgen-Und Medizintechnik GmbH
Product code	LNH
Device class	Class II
Decision date	Nov 8, 2005
Decision	Substantially Equivalent
Regulation	892.1000

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Source

View the full FDA submission: accessdata.fda.gov

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BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC

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