Brush, Dermabrasion, Manual

Device Code: 5643

Product Code(s): GED

Device Classification Information

Device Type ID5643
Device NameBrush, Dermabrasion, Manual
Regulation DescriptionManual Surgical Instrument For General Use.
Regulation Medical SpecialtyGeneral & Plastic Surgery
Review PanelGeneral & Plastic Surgery
Premarket Review Office Of Device Evaluation (ODE)
Division Of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type510(K) Exempt
CFR Regulation Number878.4800 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeGED
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5643
DeviceBrush, Dermabrasion, Manual
Product CodeGED
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionManual Surgical Instrument For General Use.
CFR Regulation Number878.4800 [🔎]
TPLC Last Update: 2019-04-02 21:10:03

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