Actuator, Syringe, For Injector, Reprocessed

Device Code: 907

Product Code(s): NKW

Device Classification Information

Device Type ID907
Device NameActuator, Syringe, For Injector, Reprocessed
Regulation DescriptionSyringe Actuator For An Injector.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Interventional Cardiology Devices Branch (ICDB)
Submission Type510(k)
CFR Regulation Number870.1670 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNKW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID907
DeviceActuator, Syringe, For Injector, Reprocessed
Product CodeNKW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSyringe Actuator For An Injector.
CFR Regulation Number870.1670 [🔎]
TPLC Last Update: 2019-04-02 19:44:42

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