FDA 510K (K122118) HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
FDA 510K (K122118) HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
Device Classification Name Shunt, Central Nervous System And Components
510(k) Number K122118
Device Name HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
Applicant Codman & Shurtleff, Inc.
Regulation Number 882.5550
Classification Product Code JXG
Date Received 07/17/2012
Decision Date 08/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
Total pages: 92
Fully redacted pages: 27
Content pages: 65
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