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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name shunt, central nervous system and components
510(k) Number K170599
Device Name SureFlo EVD Catheter
Applicant
Arkis BioSciences Inc.
1059 N. Cedar BluffRD #157
knoxville,  TN  37923
Applicant Contact joseph howell
Correspondent
Arkis BioSciences Inc.
1059 N. Cedar BluffRD #157
knoxville,  TN  37923
Correspondent Contact joseph howell
Regulation Number882.5550
Classification Product Code
JXG  
Date Received03/01/2017
Decision Date 08/31/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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