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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscope, Neurological
510(k) Number K002330
Device Name NAVIGUS PEEL AWAY INTRODUCER
Applicant
Image-Guided Neurologics, Inc.
2290 Eau Gallie Blvd.
Melbourne,  FL  32935
Applicant Contact DAVID M LEE
Correspondent
Image-Guided Neurologics, Inc.
2290 Eau Gallie Blvd.
Melbourne,  FL  32935
Correspondent Contact DAVID M LEE
Regulation Number882.1480
Classification Product Code
GWG  
Date Received08/01/2000
Decision Date 10/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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