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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, Long-Term Greater Than 30 Days
510(k) Number K910622
Device Name GESCO PER-Q-CATH REPAIR KIT
Applicant
Gesco Intl., Inc.
5714 Epsilon Dr.
San Antonio,  TX  78249
Applicant Contact N BAKER
Correspondent
Gesco Intl., Inc.
5714 Epsilon Dr.
San Antonio,  TX  78249
Correspondent Contact N BAKER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/12/1991
Decision Date 03/29/1991
Decision Substantially Equivalent - Kit (SESK)
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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