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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 K922667
Device Name MIC LOW PROFILE GASTROSTOMY 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 Received04/13/1992
Decision Date 12/01/1993
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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