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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K895942
Device Name GESCO DUAL LUMEN PER-Q-CATH-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
FOZ  
Date Received10/11/1989
Decision Date 07/02/1990
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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