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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 K233445
Device Name Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter
Applicant
Integra Lifesciences Production Corporation
11 Cabot Blvd.
Mansfield,  MA  02048
Applicant Contact Amanda Erwin
Correspondent
Integra Lifesciences Production Corporation
11 Cabot Blvd.
Mansfield,  MA  02048
Correspondent Contact Jocelyn Raposo
Regulation Number882.5550
Classification Product Code
JXG  
Subsequent Product Code
HCA  
Date Received10/19/2023
Decision Date 01/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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