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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 K983476
Device Name BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
Applicant
NAVION BIOMEDICAL CORP.
312 TOSCA DR.
STOUGHTON,  MA  02072
Applicant Contact DONALD A KAY
Correspondent
NAVION BIOMEDICAL CORP.
312 TOSCA DR.
STOUGHTON,  MA  02072
Correspondent Contact DONALD A KAY
Regulation Number876.5980
Classification Product Code
KNT  
Date Received10/02/1998
Decision Date 03/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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