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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 K901753
Device Name 600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET
Applicant
CHARTERMED, INC.
70 OBERLIN AVENUE NORTH
LAKEWOOD,  NJ  08701
Applicant Contact PETER G HUSSEY
Correspondent
CHARTERMED, INC.
70 OBERLIN AVENUE NORTH
LAKEWOOD,  NJ  08701
Correspondent Contact PETER G HUSSEY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/16/1990
Decision Date 06/01/1990
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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