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510(k) Data Aggregation
K Number
K990288Device Name
FREE FLOW SAFETY DEVICE, MODEL MG 245052
Manufacturer
Date Cleared
1999-02-24
(26 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
TEVA MEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use with any I.V. set assembled on commercially available I.V. pumps (not equipped with free flow protection), in order to prevent free flow of drugs or I.V. fluids.
Device Description
Anti Free Flow Valve
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K Number
K974171Device Name
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
Manufacturer
Date Cleared
1997-12-19
(44 days)
Product Code
Regulation Number
880.6920Why did this record match?
Applicant Name (Manufacturer) :
TEVA MEDICAL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Subcutaneous injection of Copaxone®.
Device Description
Not Found
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