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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 K823503
Device Name P-S CSF-VENTRICULAR CATHETER, FLANGED
Applicant
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number882.5550
Classification Product Code
JXG  
Date Received11/24/1982
Decision Date 03/09/1983
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
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