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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Holder, Head, Neurosurgical (Skull Clamp)
510(k) Number K031885
Device Name NAVIGUS PASSIVE HEAD RESTRAINT SYSTEM, MODEL HR-XXX
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 Number882.4460
Classification Product Code
HBL  
Date Received06/18/2003
Decision Date 08/21/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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