FDA.report

510(k) K974171

Device
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
Applicant
TEVA MEDICAL, LTD.
510(k) number
K974171
Product code
KZH  
Decision
Substantially Equivalent (SESE)
Decision date
1997-12-19
Date received
1997-11-05
Regulation
880.6920
Classification name
Introducer, Syringe Needle
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
HARRY LEINWAND
Address
1510 Delp Dr. Kulpsville PA US 19443 19443

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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