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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K935512
Device Name CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE
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
KNT  
Date Received11/16/1993
Decision Date 08/29/1996
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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