Medline ENfit OTC Feeding Syringe

Enteral Syringes With Enteral Specific Connectors

Medline Industries, Inc.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Enfit Otc Feeding Syringe.

Pre-market Notification Details

Device IDK202285
510k NumberK202285
Device Name:Medline ENfit OTC Feeding Syringe
ClassificationEnteral Syringes With Enteral Specific Connectors
Applicant Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
ContactDinah Rincones
CorrespondentDinah Rincones
Medline Industries, Inc. Three Lakes Drive Northfield,  IL  60093
Product CodePNR  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-12
Decision Date2020-10-09

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.