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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 K924065
Device Name MIC PEG TUBE
Applicant
MEDICAL INNOVATIONS CORP.
1595 MC-CANDLESS DR.
MILPITAS,  CA  95035
Applicant Contact DENNIS WONG
Correspondent
MEDICAL INNOVATIONS CORP.
1595 MC-CANDLESS DR.
MILPITAS,  CA  95035
Correspondent Contact DENNIS WONG
Regulation Number876.5980
Classification Product Code
KNT  
Date Received07/27/1992
Decision Date 02/17/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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