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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Umbilical Artery
510(k) Number K896041
Device Name GESCO DUAL LUMEN UMBILICATH II-DL
Applicant
Gesco Intl., Inc.
P.O. Box 690188
San Antonio,  TX  78269
Applicant Contact GEORGE E SINKO
Correspondent
Gesco Intl., Inc.
P.O. Box 690188
San Antonio,  TX  78269
Correspondent Contact GEORGE E SINKO
Regulation Number880.5200
Classification Product Code
FOS  
Date Received10/17/1989
Decision Date 04/17/1990
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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