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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 K854616
Device Name ENTERAL FEEDING BAG
Applicant
MEDOVATIONS, INC.
102 EAST KEEFE AVE.
MILWAUKEE,  WI  53212
Applicant Contact SURY R SHONEY
Correspondent
MEDOVATIONS, INC.
102 EAST KEEFE AVE.
MILWAUKEE,  WI  53212
Correspondent Contact SURY R SHONEY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/18/1985
Decision Date 01/23/1986
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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