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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, continuous irrigation
510(k) Number K882647
Device Name GESCO CATHETERIZATION TRAY
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 Number878.4200
Classification Product Code
GBQ  
Date Received06/27/1988
Decision Date 09/09/1988
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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