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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 K940871
Device Name UMBILI-CATH-P
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 Number880.5200
Classification Product Code
FOS  
Date Received02/25/1994
Decision Date 04/29/1994
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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