Cranial COVER— 510(k) K160739

Clearance details

Applicant

Neos Surgery S.L

Product code

Code GXR

Device class

Class 2

Regulation

21 CFR 882.5250

Advisory panel

Neurology

Date received

2016-03-17

Decision date

2016-06-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cerdanyola Del Valles, ES

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