BURR HOLE COVER, MODEL XX— 510(k) K001096

Clearance details

Applicant

Image-Guided Neurologics, Inc.

Product code

Code GXR

Device class

Class 2

Regulation

21 CFR 882.5250

Advisory panel

Neurology

Date received

2000-04-04

Decision date

2000-10-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Melbourne, FL, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K001096.