SELF ADHERING NAVIGUS GUIDE


the company

Device Classification Name

neurological stereotaxic instrument

510(k) Number K001192
Device Name SELF ADHERING NAVIGUS GUIDE
Original Applicant
IMAGE-GUIDED NEUROLOGICS, INC.
2290 w. eau gallie blvd.
suite 210
melbourne, 
FL 
32935

Original Contact david m lee
Regulation Number 882.4560
Classification Product Code
HAW  
Date Received 04/12/2000
Decision Date 06/07/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized