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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K141559
Device Name V-GUIDE FOR VENTRICULOSTOMIES
Applicant
Arc Surgical, LLC
1135 W Nasa Blvd., Suite 500
Melbourne,  FL  32901
Applicant Contact CRAIG PAGAN
Correspondent
Arc Surgical, LLC
1135 W Nasa Blvd., Suite 500
Melbourne,  FL  32901
Correspondent Contact CRAIG PAGAN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/12/2014
Decision Date 02/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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