COMPAT ENTERAL DELIVERY SYSTEMS

Tubes, Gastrointestinal (and Accessories)

SANDOZ NUTRITION

The following data is part of a premarket notification filed by Sandoz Nutrition with the FDA for Compat Enteral Delivery Systems.

Pre-market Notification Details

Device IDK855098
510k NumberK855098
Device Name:COMPAT ENTERAL DELIVERY SYSTEMS
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis,  MN  55440
ContactLongely Ph.d
CorrespondentLongely Ph.d
SANDOZ NUTRITION 5320 WEST TWENTY THIRD ST. P.O. BOX 370 Minneapolis,  MN  55440
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-23
Decision Date1986-04-08

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