Name: Predicase
Price: 199 USD

K-number	K993936
Device name	15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE
Applicant	Imagyn Surgical
Product code	KNW
Device class	Class II
Decision date	Dec 27, 1999
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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15MM SITESELECT BREAST BIOPSY DEVICE, 10 MM SITESELECT BREAST BIOPSY DEVICE, 5MM SITESELECT BREAST BIOPSY DEVICE

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