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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 K852707
Device Name GASTRO-ENTEROSTOMY TUBE
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 Received06/26/1985
Decision Date 08/14/1985
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
Recalls CDRH Recalls
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