Anchor, Fascial

Device Code: 5762

Product Code(s): NEH

Device Classification Information

Device Type ID5762
Device NameAnchor, Fascial
Regulation DescriptionImplantable Clip.
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)
CFR Regulation Number878.4300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNEH
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5762
DeviceAnchor, Fascial
Product CodeNEH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionImplantable Clip.
CFR Regulation Number878.4300 [🔎]
TPLC Last Update: 2019-04-02 21:12:07

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