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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 K941228
Device Name ENDOLUMINAL ACCESS TUBE
Applicant
MED INSTITUTE, INC.
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Applicant Contact NEAL E FEARNOT
Correspondent
MED INSTITUTE, INC.
P.O. BOX 2402
WEST LAFAYETTE,  IN  47906
Correspondent Contact NEAL E FEARNOT
Regulation Number876.5980
Classification Product Code
KNT  
Subsequent Product Code
GCJ  
Date Received03/15/1994
Decision Date 09/27/1995
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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