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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K002765
Device Name LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
Applicant
Integra Neurosciences
5955 Pacific Center Blvd.
San Diego,  CA  92121
Applicant Contact NANCY MATHEWSON
Correspondent
Integra Neurosciences
5955 Pacific Center Blvd.
San Diego,  CA  92121
Correspondent Contact NANCY MATHEWSON
Regulation Number882.1620
Classification Product Code
GWM  
Date Received09/05/2000
Decision Date 11/24/2000
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
Recalls CDRH Recalls
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