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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 K931989
Device Name VENTRI-CATH
Applicant
GESCO INTL., INC.
P.O. BOX 690188
SAN ANTONIO,  TX  78269
Applicant Contact CLYDE N BAKER
Correspondent
GESCO INTL., INC.
P.O. BOX 690188
SAN ANTONIO,  TX  78269
Correspondent Contact CLYDE N BAKER
Regulation Number882.5550
Classification Product Code
JXG  
Date Received04/22/1993
Decision Date 07/21/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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