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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 K233448
Device Name Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set
Applicant
Integra LifeSciences Production Corporation
11 Cabot Boulevard
Mansfield,  MA  02048
Applicant Contact Amanda Erwin
Correspondent
Integra LifeSciences Production Corporation
11 Cabot Boulevard
Mansfield,  MA  02048
Correspondent Contact Jocelyn Raposo
Regulation Number882.5550
Classification Product Code
JXG  
Date Received10/20/2023
Decision Date 12/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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