Silicone, Liquid, Injectable

Device Code: 5924

Product Code(s): KGM

Device Classification Information

Device Type ID5924
Device NameSilicone, Liquid, Injectable
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeKGM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5924
DeviceSilicone, Liquid, Injectable
Product CodeKGM
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 21:14:35

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