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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 K853253
Device Name CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI
Applicant
CORPAK CO.
100 CHADDICK DR.
WHEELING,  IL  60090
Applicant Contact EDWARDS
Correspondent
CORPAK CO.
100 CHADDICK DR.
WHEELING,  IL  60090
Correspondent Contact EDWARDS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/02/1985
Decision Date 11/05/1985
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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