Guard, Skin Graft

Device Code: 5738

Product Code(s): LZM

Device Classification Information

Device Type ID5738
Device NameGuard, Skin Graft
Regulation DescriptionNonresorbable Gauze/sponge For External 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 Number878.4014 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeLZM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5738
DeviceGuard, Skin Graft
Product CodeLZM
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNonresorbable Gauze/sponge For External Use.
CFR Regulation Number878.4014 [🔎]
TPLC Last Update: 2019-04-02 21:11:42

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