EnteraLoc Flow

Gastrointestinal Tubes With Enteral Specific Connectors

Vonco Products

The following data is part of a premarket notification filed by Vonco Products with the FDA for Enteraloc Flow.

Pre-market Notification Details

Device IDK210971
510k NumberK210971
Device Name:EnteraLoc Flow
ClassificationGastrointestinal Tubes With Enteral Specific Connectors
Applicant Vonco Products 10826 250th Avenue Trevor,  WI  53179
ContactChristie Marr
CorrespondentChristie Marr
Vonco Products 10826 250th Avenue Trevor,  WI  53179
Product CodePIF  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-31
Decision Date2021-08-18

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