Medela Low Dose Enteral Syringe

Enteral Syringes With Enteral Specific Connectors

Medela, Inc.

The following data is part of a premarket notification filed by Medela, Inc. with the FDA for Medela Low Dose Enteral Syringe.

Pre-market Notification Details

Device IDK161811
510k NumberK161811
Device Name:Medela Low Dose Enteral Syringe
ClassificationEnteral Syringes With Enteral Specific Connectors
Applicant Medela, Inc. 785 Challenger Street Brea,  CA  92821
ContactFergie Ferguson
CorrespondentFergie Ferguson
Medela, Inc. 785 Challenger Street Brea,  CA  92821
Product CodePNR  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-01
Decision Date2017-02-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00020451101323 K161811 000
20020451101303 K161811 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.