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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 K925261
Device Name NUTRICARE ENTERAL FEEDING TUBE
Applicant
ENTRACARE CORP.
15731 WEST 100TH TERRACE
LENEXA,  KS  66219
Applicant Contact AL BOEDEKER
Correspondent
ENTRACARE CORP.
15731 WEST 100TH TERRACE
LENEXA,  KS  66219
Correspondent Contact AL BOEDEKER
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/19/1992
Decision Date 02/17/1994
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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