GASTRO-ENTEROSTOMY TUBE

Tubes, Gastrointestinal (and Accessories)

MEDICAL INNOVATIONS CORP.

The following data is part of a premarket notification filed by Medical Innovations Corp. with the FDA for Gastro-enterostomy Tube.

Pre-market Notification Details

Device IDK852707
510k NumberK852707
Device Name:GASTRO-ENTEROSTOMY TUBE
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant MEDICAL INNOVATIONS CORP. 43A SUNOL ST. San Jose,  CA  95126
ContactStephen K Parks
CorrespondentStephen K Parks
MEDICAL INNOVATIONS CORP. 43A SUNOL ST. San Jose,  CA  95126
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-26
Decision Date1985-08-14

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