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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, peritoneal dialysis, single use
510(k) Number K872221
Device Name DIALY-NATE SET & DIALY-NATE CATHETER
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 Number876.5630
Classification Product Code
FKO  
Date Received06/09/1987
Decision Date 10/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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