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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 K940548
Device Name MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE
Applicant
MEDICAL INNOVATIONS CORP.
1595 MC-CANDLESS DR.
MILPITAS,  CA  95035
Applicant Contact DENNIS L WONG
Correspondent
MEDICAL INNOVATIONS CORP.
1595 MC-CANDLESS DR.
MILPITAS,  CA  95035
Correspondent Contact DENNIS L WONG
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/07/1994
Decision Date 02/22/1995
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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