Tape, Surgical, Internal

Device Code: 5739

Product Code(s): MCA

Device Classification Information

Device Type ID5739
Device NameTape, Surgical, Internal
Regulation DescriptionSurgical Mesh.
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 Two - Surgical (GSDB2)
Submission Type510(k)
CFR Regulation Number878.3300 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMCA
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5739
DeviceTape, Surgical, Internal
Product CodeMCA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSurgical Mesh.
CFR Regulation Number878.3300 [🔎]
TPLC Last Update: 2019-04-02 21:11:44

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