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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 K911607
Device Name GESCO UMBILI-CATH
Applicant
Gesco Intl., Inc.
5714 Epsilon Dr.
San Antonio,  TX  78249
Applicant Contact CLYDE N BAKER
Correspondent
Gesco Intl., Inc.
5714 Epsilon Dr.
San Antonio,  TX  78249
Correspondent Contact CLYDE N BAKER
Regulation Number880.5200
Classification Product Code
FOS  
Date Received04/10/1991
Decision Date 06/11/1991
Decision Substantially Equivalent (SESE)
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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