FDA.report

510(k) K160642

Device
Medline ENFit Syringe
Applicant
Medline Industries, Inc.
510(k) number
K160642
Product code
PIF  
Decision
Substantially Equivalent (SESE)
Decision date
2016-11-29
Date received
2016-03-07
Regulation
876.5980
Classification name
Gastrointestinal Tubes With Enteral Specific Connectors
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Stephanie Blair
Address
One Medline Pl. Mundelein IL US 60060 60060

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
20888277677712MedlineMEDLINE INDUSTRIES, INC.2021-10-15

Legacy Summary

summary

FDA Review

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