FDA.report

510(k) K990288

Device
FREE FLOW SAFETY DEVICE, MODEL MG 245052
Applicant
TEVA MEDICAL, LTD.
510(k) number
K990288
Product code
FPA  
Decision
Substantially Equivalent (SESE)
Decision date
1999-02-24
Date received
1999-01-29
Regulation
880.5440
Classification name
Set, Administration, Intravascular
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
MARYANN MELUS
Address
482 Hudson Ter. Englewood Cliffs NJ US 07632 07632

FDA Registration Numbers

Source Documents

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

Legacy Summary

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FDA Review

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