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FDA 510(k), K974620, AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
FDA 510(k), K974620, AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
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510(K) Number: K974620
Device Name: AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Manufacturer: TRACE AMERICA, INC.
Device Classification Name: enzymatic method, ammonia
Regulation Number: 862.1065
Classification Product Code: JIF
Date Received: 12/11/1997
Decision Date: 01/02/1998
Regulation Medical Specialty: Clinical Chemistry
Device Name: AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
Manufacturer: TRACE AMERICA, INC.
Device Classification Name: enzymatic method, ammonia
Regulation Number: 862.1065
Classification Product Code: JIF
Date Received: 12/11/1997
Decision Date: 01/02/1998
Regulation Medical Specialty: Clinical Chemistry
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