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510(k) Data Aggregation
K Number
K964060Device Name
COPAXONE (COPOLYMER-1 FOR INJECTION) SELF-INJECTION ADMINISTRATION PACKAGE
Manufacturer
Date Cleared
1996-12-24
(76 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
TRAVENOL LABORATORIES (ISRAEL) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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