Name: Predicase
Price: 199 USD

K-number	K192945
Device name	7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
Applicant	7D Surgical, Inc.
Product code	HAW
Device class	Class II
Decision date	Nov 27, 2019
Decision	Substantially Equivalent
Regulation	882.4560

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Source

View the full FDA submission: accessdata.fda.gov

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7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application

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