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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 K844174
Device Name FLEXIBLE STAINLESS STEEL STYLET FOR ENTERNAL FEEDI
Applicant
EXCO, INC.
P.O. BOX 1348
WALL,  NJ  07719
Applicant Contact JOHN Y CHALAKANI
Correspondent
EXCO, INC.
P.O. BOX 1348
WALL,  NJ  07719
Correspondent Contact JOHN Y CHALAKANI
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/25/1984
Decision Date 12/07/1984
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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