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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 K852363
Device Name MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT
Applicant
Medical Innovations Corp.
43a Sunol St.
San Jose,  CA  95126
Applicant Contact STEPHEN K PARKS
Correspondent
Medical Innovations Corp.
43a Sunol St.
San Jose,  CA  95126
Correspondent Contact STEPHEN K PARKS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/04/1985
Decision Date 08/09/1985
Decision Substantially Equivalent (SESE)
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
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