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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 K970178
Device Name CLOG ZAPPER ENTERAL FEEDING TUBE DECLOGGING SYSTEM
Applicant
CORPAK, INC.
100 CHADDICK DR.
WHEELING,  IL  60090
Applicant Contact ROBERT E BOOTH
Correspondent
CORPAK, INC.
100 CHADDICK DR.
WHEELING,  IL  60090
Correspondent Contact ROBERT E BOOTH
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/17/1997
Decision Date 07/21/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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