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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 K893209
Device Name ENTERA-FLO SPIKE SET
Applicant
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Applicant Contact RONALD GUIDO
Correspondent
DELMED, INC.
120 ALBANY ST.
P.O. BOX 2623
NEW BRUNSWICK,  NJ  08903
Correspondent Contact RONALD GUIDO
Regulation Number876.5980
Classification Product Code
KNT  
Date Received04/27/1989
Decision Date 07/24/1989
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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