510(k) K031407

Device
ROSS EMBRACE ENTERAL PUMP
Applicant
Ross Product Div. Abbott Laboratories
510(k) number
K031407
Product code
LZH
Decision
Substantially Equivalent (SESE)
Decision date
2003-05-20
Date received
2003-05-05
Regulation
880.5725
Classification name
Pump, Infusion, Enteral
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
DANIEL HAMILTON
Address
625 Cleveland Ave. Columbus OH US 43215 43215

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

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