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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Syringe Needle
510(k) Number K974171
Device Name COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
Applicant
Teva Medical, Ltd.
1510 Delp Dr.
Kulpsville,  PA  19443
Applicant Contact HARRY LEINWAND
Correspondent
Teva Medical, Ltd.
1510 Delp Dr.
Kulpsville,  PA  19443
Correspondent Contact HARRY LEINWAND
Regulation Number880.6920
Classification Product Code
KZH  
Date Received11/05/1997
Decision Date 12/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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