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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 K901134
Device Name ENTERA-FLO REPLACEMENT GASTROSTOMY TUBE
Applicant
FRESENIUS PHARMA
120 ALBANY STREET, SUITE 700
NEW BRUNSWICK,  NJ  08903
Applicant Contact RONALD GUIDO
Correspondent
FRESENIUS PHARMA
120 ALBANY STREET, SUITE 700
NEW BRUNSWICK,  NJ  08903
Correspondent Contact RONALD GUIDO
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/12/1990
Decision Date 06/20/1990
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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