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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 K890093
Device Name PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SET
Applicant
KELLS MEDICAL, INC.
1518 - CONESTOGA COURT
REDLANDS,  CA  92373
Applicant Contact M GREY
Correspondent
KELLS MEDICAL, INC.
1518 - CONESTOGA COURT
REDLANDS,  CA  92373
Correspondent Contact M GREY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/10/1989
Decision Date 07/24/1989
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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