Name: Predicase
Price: 199 USD

K-number	K233294
Device name	Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
Applicant	Itp Innovative Tomography Products GmbH
Product code	KNW
Device class	Class II
Decision date	Jun 18, 2024
Decision	Substantially Equivalent
Regulation	876.1075

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Source

View the full FDA submission: accessdata.fda.gov

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Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM

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