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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, gastro-enterostomy
510(k) Number K901501
Device Name CORPAK GASTROSTOMY TUBE
Applicant
CORPAK CO.
100 CHADDICK DR.
WHEELING,  IL  60090
Applicant Contact ERIK ANDERSEN
Correspondent
CORPAK CO.
100 CHADDICK DR.
WHEELING,  IL  60090
Correspondent Contact ERIK ANDERSEN
Regulation Number876.5980
Classification Product Code
KGC  
Date Received03/30/1990
Decision Date 06/11/1990
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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