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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 K881162
Device Name ENTERA* ENTERAL FEEDING BAG
Applicant
SMASH ENT., INC.
3585 LEXINGTON AVENUE NORTH
SUITE 258
ARDEN HILLS,  MN  55126
Applicant Contact JANET L ZAHN
Correspondent
SMASH ENT., INC.
3585 LEXINGTON AVENUE NORTH
SUITE 258
ARDEN HILLS,  MN  55126
Correspondent Contact JANET L ZAHN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/18/1988
Decision Date 06/03/1988
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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